Preterm BirthNFPNCT03360539
Nurse-Family Partnership Impact Evaluation in South Carolina
A study testing Nurse-Family Partnership in people with Preterm Birth and Injuries, run by Harvard School of Public Health (HSPH) at 9 sites in United States.
Trial summary
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. Read more about this study
- Who is it for?
- Ages 15 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Injuries, Maternal Behavior
- What is being tested?
- Nurse-Family Partnership
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,670 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Apr 2016to 1 Apr 2046
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- No previous live births
- Currently pregnant
- Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment
- Ages 15-55
- Income level meets Medicaid eligibility criteria
Show all 9Show fewer
- Live within an area serviced by a NFP Implementing Agency
- Not currently enrolled in the study
- Not incarcerated or living in lock down facilities
Who cannot join
- Men
- Women who have had a previous live birth
- Women who are not currently pregnant
- Women who are past their 28th week of gestation (i.e. greater than or equal to 28 weeks, 0 days) at time of recruitment
- Women who are younger than 15 or older than 55 years of age
- Women whose income level does not meet Medicaid eligibility criteria
Show all 9Show fewer
- Women who live outside of an area serviced by a NFP Implementing Agency
- Women who are currently enrolled in the study
- Women who are currently incarcerated or living in a lock down facility
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Nurse-Family Partnership of Anderson County
Anderson, South Carolina, 29625
NFP of Berkeley/Charleston/Dorchester Counties
Charleston, South Carolina, 29405
Nurse-Family Partnership of Lexington-Richland Co.
Columbia, South Carolina, 29204
Nurse-Family Partnership of Horry County
Conway, South Carolina, 29526
McLeod Health NFP
Florence, South Carolina, 29506
Nurse-Family Partnership of Greenville County
Greenville, South Carolina, 29605
Carolina Health Centers NFP
Greenwood, South Carolina, 29646
Family Solutions of the Lowcountry NFP
Orangeburg, South Carolina, 29118
Spartanburg Regional Hospital NFP
Spartanburg, South Carolina, 29303
About this study
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
Read the detailed description
This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll pregnant women who are income-eligible for Medicaid, less than 28 weeks pregnant, and have not had a previous live birth. All eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to NFP or to a control group that is not. Two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. Control group members will have access to the standard of care and whatever other programs and services are available in the community.
The investigators will assess the effect of NFP on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. Several of the outcomes the investigators will evaluate are required as part of the Medicaid waiver and pay-for-success financing model.
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Being tested
- Nurse-Family Partnership
- Medical subject headings
- Premature Birth, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Family PartnershipBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment-NFP | Experimental | NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. Receives: Behavioral: Nurse-Family Partnership |
| Control | No intervention | Control group members have access to the standard of care and whatever other programs and services are available in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Composite Birth Outcome
Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).
Measured: 0-7 days after index birth; vital records, mortality records, and fetal death records
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect
Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).
Measured: within 24 months after index birth; Medicaid claims or hospital discharge data
Number of Participants With an Inter-birth Interval of < 21 Months
Having a subsequent birth within the first 21 months of the index birth
Measured: within 21 months after index birth; vital records
Secondary outcomes (57)
Number of Participants With an Infant Born Small for Gestational Age (SGA)
Infant birth weight below the 10th percentile for infants of the same gestational age
Measured: At index birth; vital records
Number of Participants With an Infant Born Large for Gestational Age (LGA)
Infant birth weight above the 90th percentile for infants of the same gestational age
Measured: At index birth birth; vital records
Number of Participants With an Infant Born With Low Birth Weight (LBW)
Number of participants with an infant born with a birth weight of less than 2500 grams.
Measured: At index birth; vital records
Number of Participants With an Infant With Very Low Birth Weight
Number of participants with an infant born with a birth weight of less than 1500 grams.
Measured: At index birth; vital records
Birth Weight (Continuous)
A continuous measure of infant birth weight (grams)
Measured: At index birth; vital records
Number of Participants With a Preterm Birth
Infant born before 37 weeks' gestation (obstetric estimate)
Measured: At index birth; vital records
Number of Participants With an Extremely Preterm Birth
Number of participants with an infant born before 28 weeks' gestation.
Measured: At index birth; vital records
Gestational Age at Birth
Gestational age at birth in weeks (continuous)
Measured: At index birth; vital records
Number of Participants Experiencing Perinatal Mortality
Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life
Measured: Within 1 week after index birth; mortality records and fetal death records
Number of Participants With a NICU Admission of at Least Overnight
Infant admitted to the neonatal intensive care unit (NICU) for at least one night
Measured: At index birth; hospital discharge
Number of Participants Experiencing Neonatal Morbidity
Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis.
Measured: At index birth; hospital discharge
Number of Participants Experiencing Cesarean Delivery
Number of participants experiencing a cesarean delivery for their index birth.
Measured: At index birth; vital records
Number of Participants Experiencing Severe Acute Maternal Morbidity
Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC).
Measured: At index birth; hospital discharge
Number of Participants Experiencing Maternal Mortality
Number of participants experiencing all-cause mortality within one year postpartum.
Measured: Within one year after index birth; mortality records
Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse
Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum.
Measured: Within two years after index birth; Medicaid claims, hospital discharge
Number of Participants Experiencing Violence or Homicide
Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code
Measured: Within 2 years after index birth; Medicaid claims, mortality records
Number of Participants With a Postpartum Visit
Number of participants with a postpartum visit in first 12 weeks after an index birth.
Measured: Within 12 weeks after index birth; Medicaid claims
Number of Participants Who Received Adequate Prenatal Care
With adequacy defined using the Adequacy of Prenatal Care Utilization Index (APNCU), where prenatal care began by the 4th month and at least 80% of recommended visits were attended
Measured: At index birth; vital records
Number of Emergency Department Visits During Pregnancy
Number of emergency department visits during pregnancy.
Measured: At index birth; hospital discharge
Number of Participants With a Dental Visit During Pregnancy
Number of participants with a dental visit during pregnancy (preventive or treatment).
Measured: At index birth; Medicaid claims and dental records
Number of Participants With an Ultrasound at 18-22 Weeks
Number of participants with an ultrasound (anatomy scan) at 18-22 weeks.
Measured: 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.
Number of Participants Who Received Prenatal Screens
Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Measured: At index birth; Medicaid claims
Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)
Received a glucose screen at 24-28 weeks' gestation.
Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Measured: At 24-28 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Tdap Vaccination (27-36 Weeks)
Received Tdap vaccination at 27-36 weeks' gestation.
Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Measured: At 27-36 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Group B Streptococcus Test (35-37 Weeks)
Received Group B streptococcus test at 35-37 weeks' gestation.
Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers.
Measured: At 35-37 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Mental Health Diagnosis or Outpatient Treatment
Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit
Measured: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction
Number of participants with a diagnosis of depression/anxiety/stress reaction.
Measured: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Antidepressant Prescription
Number of participants with an antidepressant prescription.
Measured: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Outpatient Mental Health Visit
Number of participants with at least one outpatient mental health visit.
Measured: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Mental Health Treatment Follow up
Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase")
Measured: Within 120 days of treatment initiation; Medicaid claims
Number of Participants With a Mental Health Related Emergency/Inpatient Visit
Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Measured: During index pregnancy or 12 months postpartum; Hospital discharge
Number of Mental Health Related Emergency/Inpatient Visits
Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction
Measured: During index pregnancy or 12 months postpartum; Hospital discharge
Number of Participants Whose Child Experienced a Major Injury
Health care encounter or mortality associated with ICD codes indicating major injury
Measured: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Participants Whose Child Experienced Concern for Abuse or Neglect
Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect
Measured: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Injuries
Number of injuries for child
Measured: Within 24 months after index birth; hospital discharge
Number of Participants Whose Child Had an Emergency Department Visit
Number of participants whose child had at least one visit to the emergency department.
Measured: Within 24 months after index birth; hospital discharge
Number of Child Emergency Department Visits
Total number of child visits to the emergency department (without admission)
Measured: Within 24 months after index birth; hospital discharge
Number of Participants Experiencing Child Mortality
All-cause child mortality in first 24 months of life
Measured: Within 24 months after index birth; Mortality records
Number of Participants With Recommended Number of Well-child Visits
Number of participants that received the recommended number of well-child visits.
Measured: At 15 months after index birth; Medicaid claims
Number of Participants With Lead Screening
Number of participants whose child received at least one lead screening.
Measured: At 15 months after index birth; Medicaid claims
Number of Participants With Developmental Screening
Number of participants whose child received at least one developmental screening.
Measured: At 12 months after index birth; Medicaid claims
Number of Participants With a Dental Visit
Child receives a dental screen at least once in first 24 months
Measured: Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With Fluoride Treatment
Share with recommended fluoride treatments received by child
Measured: Within 24 months after index birth; Medicaid claims and dental records
Number of Participants With an Inter-birth Interval of < 24 Months
Having a subsequent birth within the first 24 months of the index birth
Measured: Within 24 months after index birth; vital records
Number of Participants With an Inter-birth Interval of < 15 Months
Having a subsequent birth within the first 15 months of the index birth
Measured: Within 15 months after index birth; vital records
Inter-birth Interval
Continuous measure of inter-birth interval
Measured: 60 months after index birth; vital records
Number of Participants With a Family Planning Visit (6 Weeks)
Number of participants who received any family planning-related counseling or service.
Measured: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks)
Received implant, immediate postpartum long-acting reversible contraception (IPP-LARC), long-acting reversible contraception (LARC), or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
Measured: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks)
Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum.
Measured: Within 6 weeks after index birth; Medicaid claims, hospital discharge
Number of Participants With a Family Planning Visit (1 Year)
Number of participants who received any family planning-related counseling or service in the first year postpartum.
Measured: Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year)
Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills
Measured: Within 12 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year)
Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum.
Measured: Within 12 months after index birth; Medicaid claims, hospital discharge
Time to First Take-up of Family Planning Counseling or Service
Months from pregnancy to first take up of family planning counseling or service
Measured: Within 24 months after index birth; Medicaid claims, hospital discharge
Time to First Take-up of Highly Effective Contraceptive Method
Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization)
Measured: Within 24 months after index birth; Medicaid claims, hospital discharge
Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits
Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy.
Measured: During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively
Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits
Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families
Measured: Within 24 months after index birth; South Carolina Department of Social Services data
Number of Participants With SNAP or TANF Benefit Churn
Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year
Measured: Within 24 months after index birth; South Carolina Department of Social Services data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start1 Apr 2016
- Primary completion1 Apr 2023
- Study completion1 Apr 2046 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.
- Masking
- None (open label)
- Enrolment
- 5,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab, University of Chicago
- Responsible party
- Principal investigator, Margaret McConnell, Harvard School of Public Health (HSPH)
- Investigators
- Margaret McConnell, PhD, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360539
- Sponsor's protocol ID
- IRB15-2939
- Acronym
- NFP
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2017
- Last updated
- 12 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Swanson K, Ayers S, Oviedo D, Zhou RA, Bates MA, Baicker K, Chien AT, McConnell M. Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):857-866. doi: 10.1001/jamapediatrics.2025.1600.
PubMed 40522648Rokicki S, Oviedo D, Perreault N, Bates MA, Zhou RA, Baicker K, McConnell MA. Impact of nurse home visiting on take-up of social safety net programs in a Medicaid population. Health Aff Sch. 2025 Apr 2;3(4):qxaf038. doi: 10.1093/haschl/qxaf038. eCollection 2025 Apr.
PubMed 40177469Rokicki S, Oviedo D, Perreault N, Zera C, McGregor AJ, Bates MA, Zhou RA, Baicker K, McConnell MA. Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605.
PubMed 39714843Steenland MW, Oviedo D, Bates MA, Zhou A, Zera C, Baicker K, McConnell MA. Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):3-12. doi: 10.1097/AOG.0000000000005786. Epub 2024 Nov 14.
PubMed 39671266McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703.
PubMed 35788794McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9.
PubMed 33276816
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Family Partnership Impact Evaluation in South Carolina
- ClinicalTrials.gov ID
- NCT03360539
- Acronym / sponsor ID
- NFP / IRB15-2939
- Conditions
- Preterm Birth, Injuries, Maternal Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,670 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Abdul Latif Jameel Poverty Action Lab, University of Chicago
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2046 (estimated)
- First posted
- 4 Dec 2017 (actual)
- Results
- Posted 12 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
Detailed description
This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll pregnant women who are income-eligible for Medicaid, less than 28 weeks pregnant, and have not had a previous live birth. All eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to NFP or to a control group that is not. Two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. Control group members will have access to the standard of care and whatever other programs and services are available in the community.
The investigators will assess the effect of NFP on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. Several of the outcomes the investigators will evaluate are required as part of the Medicaid waiver and pay-for-success financing model.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.
| Arm | Type | Receives |
|---|---|---|
| Treatment-NFP | Experimental | Behavioral: Nurse-Family PartnershipNFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. |
| Control | No intervention | –Control group members have access to the standard of care and whatever other programs and services are available in the community. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Female
- No previous live births
- Currently pregnant
- Gestation period less than 28 weeks (i.e. less than or equal to 27 weeks, 6 days) at time of recruitment
- Ages 15-55
Key exclusion criteria (9 listed)
- Men
- Women who have had a previous live birth
- Women who are not currently pregnant
- Women who are past their 28th week of gestation (i.e. greater than or equal to 28 weeks, 0 days) at time of recruitment
- Women who are younger than 15 or older than 55 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Family Partnership | Behavioural | Treatment-NFP |
Primary outcome
Number of Participants With a Composite Birth Outcome
Time frame: 0-7 days after index birth; vital records, mortality records, and fetal death records
Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life).
Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect
Time frame: within 24 months after index birth; Medicaid claims or hospital discharge data
Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren).
Number of Participants With an Inter-birth Interval of < 21 Months
Time frame: within 21 months after index birth; vital records
Having a subsequent birth within the first 21 months of the index birth
57 secondary outcomes
Number of Participants With an Infant Born Small for Gestational Age (SGA)
Time frame: At index birth; vital records
Number of Participants With an Infant Born Large for Gestational Age (LGA)
Time frame: At index birth birth; vital records
Number of Participants With an Infant Born With Low Birth Weight (LBW)
Time frame: At index birth; vital records
Number of Participants With an Infant With Very Low Birth Weight
Time frame: At index birth; vital records
Birth Weight (Continuous)
Time frame: At index birth; vital records
Number of Participants With a Preterm Birth
Time frame: At index birth; vital records
Number of Participants With an Extremely Preterm Birth
Time frame: At index birth; vital records
Gestational Age at Birth
Time frame: At index birth; vital records
Number of Participants Experiencing Perinatal Mortality
Time frame: Within 1 week after index birth; mortality records and fetal death records
Number of Participants With a NICU Admission of at Least Overnight
Time frame: At index birth; hospital discharge
Number of Participants Experiencing Neonatal Morbidity
Time frame: At index birth; hospital discharge
Number of Participants Experiencing Cesarean Delivery
Time frame: At index birth; vital records
Number of Participants Experiencing Severe Acute Maternal Morbidity
Time frame: At index birth; hospital discharge
Number of Participants Experiencing Maternal Mortality
Time frame: Within one year after index birth; mortality records
Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse
Time frame: Within two years after index birth; Medicaid claims, hospital discharge
Number of Participants Experiencing Violence or Homicide
Time frame: Within 2 years after index birth; Medicaid claims, mortality records
Number of Participants With a Postpartum Visit
Time frame: Within 12 weeks after index birth; Medicaid claims
Number of Participants Who Received Adequate Prenatal Care
Time frame: At index birth; vital records
Number of Emergency Department Visits During Pregnancy
Time frame: At index birth; hospital discharge
Number of Participants With a Dental Visit During Pregnancy
Time frame: At index birth; Medicaid claims and dental records
Number of Participants With an Ultrasound at 18-22 Weeks
Time frame: 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims.
Number of Participants Who Received Prenatal Screens
Time frame: At index birth; Medicaid claims
Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks)
Time frame: At 24-28 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Tdap Vaccination (27-36 Weeks)
Time frame: At 27-36 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Group B Streptococcus Test (35-37 Weeks)
Time frame: At 35-37 weeks' gestation of index pregnancy; Medicaid claims
Number of Participants With a Mental Health Diagnosis or Outpatient Treatment
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Antidepressant Prescription
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With an Outpatient Mental Health Visit
Time frame: During index pregnancy or 60 days postpartum; Medicaid claims
Number of Participants With a Mental Health Treatment Follow up
Time frame: Within 120 days of treatment initiation; Medicaid claims
Number of Participants With a Mental Health Related Emergency/Inpatient Visit
Time frame: During index pregnancy or 12 months postpartum; Hospital discharge
Number of Mental Health Related Emergency/Inpatient Visits
Time frame: During index pregnancy or 12 months postpartum; Hospital discharge
Number of Participants Whose Child Experienced a Major Injury
Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Participants Whose Child Experienced Concern for Abuse or Neglect
Time frame: Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records
Number of Injuries
Time frame: Within 24 months after index birth; hospital discharge
Number of Participants Whose Child Had an Emergency Department Visit
Time frame: Within 24 months after index birth; hospital discharge
Number of Child Emergency Department Visits
Time frame: Within 24 months after index birth; hospital discharge
Number of Participants Experiencing Child Mortality
Time frame: Within 24 months after index birth; Mortality records
Number of Participants With Recommended Number of Well-child Visits
Time frame: At 15 months after index birth; Medicaid claims
Number of Participants With Lead Screening
Time frame: At 15 months after index birth; Medicaid claims
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40522648Swanson K, Ayers S, Oviedo D, Zhou RA, Bates MA, Baicker K, Chien AT, McConnell M. Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):857-866. doi: 10.1001/jamapediatrics.2025.1600.
- Derived from this study: PubMed 40177469Rokicki S, Oviedo D, Perreault N, Bates MA, Zhou RA, Baicker K, McConnell MA. Impact of nurse home visiting on take-up of social safety net programs in a Medicaid population. Health Aff Sch. 2025 Apr 2;3(4):qxaf038. doi: 10.1093/haschl/qxaf038. eCollection 2025 Apr.
- Derived from this study: PubMed 39714843Rokicki S, Oviedo D, Perreault N, Zera C, McGregor AJ, Bates MA, Zhou RA, Baicker K, McConnell MA. Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605.
- Derived from this study: PubMed 39671266Steenland MW, Oviedo D, Bates MA, Zhou A, Zera C, Baicker K, McConnell MA. Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):3-12. doi: 10.1097/AOG.0000000000005786. Epub 2024 Nov 14.
- Derived from this study: PubMed 35788794McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703.
- Derived from this study: PubMed 33276816McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McConnell, PhD principal investigator
Harvard School of Public Health (HSPH)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Family Partnership in people with Preterm Birth and Injuries, run by Harvard School of Public Health (HSPH) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Composite Birth Outcome (time frame: 0-7 days after index birth; vital records, mortality records, and fetal death records). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360539, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.