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Family PlanningLINCCNCT04092530

Linking Inter-professional Newborn and Contraception Care

A study testing LINCC intervention - enable co-schedule feature in people with Family Planning and Contraception, run by Rush University Medical Center at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes and affect nearly one third of women in the U.S. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Family Planning, Contraception, PostPartum
What is being tested?
LINCC intervention - enable co-schedule feature
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,518 participants
Where
5 sitesUnited States
Study dates
1 Apr 2021to 30 Jun 2024
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 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Eligible participants include women presenting with their infants at one of the 7 chosen CHC sites for their first WBV (typically 3-5 days after delivery).

Who cannot join

  • Women will be excluded if they had a tubal ligation or a long acting reversible contraception planned immediately after delivery. Additionally, women will be excluded if they needed an emergency hysterectomy due to life threatening bleeding during delivery. Any male patients will be excluded from the study because the study outcomes of contraceptive method use and pregnancy status are not applicable to males.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Friend Health

    Chicago, Illinois, 60615

  • Heartland Health Centers

    Chicago, Illinois, 60640

  • Infant Welfare Society

    Chicago, Illinois, 60647

  • Settlement Health

    New York, New York, 10029

  • Malama O ke Ola

    Wailuku, Hawaii, 96793

Other trials in United States

About this study

Official title: Linking Inter-professional Newborn and Contraception Care (LINCC) Trial - A Novel Approach to Postpartum Contraception Provision at the Well-Baby Visit

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes and affect nearly one third of women in the U.S. Rates of postpartum (PP) contraception use remain low, particularly among low-income minority women, leading to high rates of short IPI pregnancies. This proposed study aims to address the gap in the current model of PP contraception care, by developing and implementing a novel approach to link (co-schedule) PP contraception care with newborn well-baby care with the goal of improving access to timely PP contraception.

Read the detailed description

Pregnancies conceived within 18 months of a prior delivery (termed short inter-pregnancy interval [IPI]) place mothers and infants at high risk for poor health outcomes including pre-eclampsia, anemia, and preterm birth. Despite these negative health consequences, nearly one third of women experience a short IPI, highlighting a significant public health problem in the U.S. A critical approach to preventing short IPIs is to provide postpartum (PP) women with timely access to contraception. The current standard clinical practice is to have women return six weeks after delivery for a postpartum visit, at which time contraceptive needs are addressed. However, many women resume sexual activity prior to six weeks PP, and many women, particularly low-income minority women, do not present for this visit. Low rates of postpartum contraception uptake leave women vulnerable to an unplanned pregnancy and significant negative health consequences. Thus, there is an urgent need for alternative approaches to increase timely access to PP contraception to improve outcomes for women and children.

The proposed study aims to:

  1. develop a comprehensive implementation plan to link PP contraception and newborn care through co-scheduling visits in community health centers (CHC);
  2. use an effectiveness- implementation hybrid design to evaluate this novel system-level approach to linking maternal and newborn care at CHCs served by our partner organization, AllianceChicago and;
  3. assess implementation of linked PP contraception and newborn care and report on key barriers and facilitators related to successful implementation of the intervention.

Increasing access to timely contraception is a promising strategy to help women plan their families and, in turn, reduce the poor health sequela associated with short IPI pregnancies. The long-term impact of this study is to reduce negative health outcomes among PP women and infants by increasing access to patient-oriented PP contraceptive care. Findings may provide evidence supporting a paradigm shift for linked PP care and identify important insights to facilitate successful implementation of this model of care in CHCs across the nation.

Being tested
LINCC intervention - enable co-schedule feature

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LINCC intervention - enable co-schedule featureBehavioural

    Clinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit

Study groups in NCT04092530
Study groupRoleWhat they receive
Intervention - Aim 2ExperimentalDuring the intervention period, staff will capture women during the first well-baby visit (WBV) and offer to have the next visit co-scheduled for infant and contraception care. Appointments are scheduled during the discharge process at the end of each WBV. During the discharge process all women 0-6 months postpartum will be identified by clerical staff through review of each pediatric clinic beforehand and through an electronic flag alert in the infant's electronic medical record. The pre-review of pediatric clinic schedules and the use of the flag will remind staff to offer the mother a co-scheduled visit for newborn and contraceptive care at the time of the next newborn visit.
Receives: Behavioral: LINCC intervention - enable co-schedule feature
Control - Aim 2No interventionClinics will schedule postpartum contraception using normal clinic procedures.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Who Receive Contraception by Two Months Postpartum

    Using de-identified patient data collected through clinic's Electronic Health Record (EHR) system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by two months postpartum

    Measured: 2 months

Secondary outcomes (2)

  1. Number of Patients Who Receive Contraception by Six Months Postpartum

    Using de-identified patient data collected through clinic's Electronic Medical Record system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by six months postpartum

    Measured: 6 months

  2. Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies

    Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2019
  2. Study start1 Apr 2021
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2024

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Effectiveness-Implementation Hybrid Design
Masking
None (open label)
Enrolment
2,518 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04092530
Sponsor's protocol ID
1R01HD097171
Acronym
LINCC
Status last verified
Aug 2025
First submitted
9 Sep 2019
Last updated
4 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haider S, Ott E, Moore A, Rankin K, Campbell R, Mohanty N, Gemkow JW, Caskey R. Linking Inter-professional Newborn and Contraception Care (LINCC) trial: Protocol for a stepped wedge cluster randomized trial to link postpartum contraception care with routine Well-Baby Visits. Contemp Clin Trials. 2024 Oct;145:107659. doi: 10.1016/j.cct.2024.107659. Epub 2024 Aug 8.

    PubMed 39121991

Questions about this trial

What is this clinical trial studying?

A study testing LINCC intervention - enable co-schedule feature in people with Family Planning and Contraception, run by Rush University Medical Center at 5 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 4 Sep 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 Patients Who Receive Contraception by Two Months Postpartum (time frame: 2 months). 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 NCT04092530, which also lists 1 linked publication.

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 4 Sep 2025.

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