ContraceptionCOMSENCT03389958
Maternity Care and Contraception
An observational study of Contraception and Maternal Care Patterns, run by Oregon Health and Science University at 3 sites in Colombia.
Trial summary
This is a multicenter observational study of implementation of postpartum contraceptive counseling and provision into the maternity care setting in Colombia, South America. The primary aim is to determine proportion of uptake of highly-effective contraceptive use after these methods become available immediately… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Maternal Care Patterns, Pregnancy Related
- What is being tested?
- Counseling and provision of contraception
- How many people
- 299 participants
- Where
- 3 sitesColombia
- Study dates
- 1 Oct 2015to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women undergoing management of a pregnancy that results in live birth over 20 weeks gestation during the same hospitalization at three public hospitals in Colombia (in Cartagena and Medellin).
Who may be able to join
- Pregnant woman in labor
- Live fetus over 20 weeks gestation
- Age >14 years
Who cannot join
- No medical exclusions for the contraceptive method chosen
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites
Maternidad Rafael Calvo
Cartagena
Hospital General de Medellin
Medellín
Metrosalud Manrique
Medellín
About this study
Official title: Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception
This is a multicenter observational study of implementation of postpartum contraceptive counseling and provision into the maternity care setting in Colombia, South America. The primary aim is to determine proportion of uptake of highly-effective contraceptive use after these methods become available immediately postpartum. Secondary aims include rapid repeat pregnancy rates, use of other types of contraception, breastfeeding continuation, and visualization of IUD strings after immediate postpartum placement.
Read the detailed description
This pre- post-intervention study will take place in Colombia, South America in 2 cities: Medellin (2 sites and Cartagena 1 site). The main objective is to determine the proportion of contraceptive usage by women who have just had a baby, before and after the introduction of specialized contraceptive counseling into maternity care and availability of the most effective contraceptive methods:
Group 1 (Standard of care) participants will be asked about intention for contraception usage upon hospital discharge after maternity care.
Group 2 (Intervention) participants will receive standardized contraceptive counseling and immediate access to the method of choice, including long acting reversible contraception (LARC) and other locally available methods. LARC methods available in Colombia include the copper-T intrauterine device (IUD) and Jadelle® implant, both of which are safe for usage in postpartum women.
Both groups will undergo follow- up via phone at 6-8 weeks, and 6 and 12 months postpartum to determine contraceptive continuation, repeat pregnancy, and to track any complications with the usage of LARC, including infection and contraceptive failure. For subjects with an IUD, an additional visit would take place at 8-10 days to determine need for IUD string trimming and visualization of strings.
The intervention will include introduction of specialized standardized contraceptive counseling to occur during inpatient maternity care and immediate postpartum availability of LARC methods. Currently, contraceptive counseling is left to the postpartum primary care setting and obstetric providers are not trained for immediate IUD placement. LARC devices are not typically available in the inpatient setting. Providers and staff of all levels will be trained in standardized contraceptive counseling methods. Obstetric providers will be trained in immediate postplacental IUD insertion. Staff nurses and providers will have access to company-sponsored implant insertion training programs.
The proportion of participants using LARC methods after implementation of the intervention will be compared to the proportion choosing LARC prior to the intervention. Additionally, the outcomes of women choosing non-LARC methods will be compared to those choosing LARC methods.
The study has received funding by the Colombian grant agency, Colciencias. Regulatory oversight has previously been granted by the University of Antioquia's (Medellin, Colombia) Institutional Review Board. Research operations are managed by the local Colombian organization, NACER, with support of research design and methods, statistical analysis, and medical expertise and trainings provided by clinicians from OHSU. Day to day research operations will be managed by research coordinators at each of the three maternity care hospital sites with support and monitoring by NACER and by OHSU clinicians.
The role of OHSU clinicians will be to provide research infrastructure and clinical support via remote communications, to provide initial training of trainers, to provide monitoring of recruitment and counseling methods, to help in the creation and monitor quality of data collection forms, and to perform statistical analyses. OHSU will not participate in recruitment of participants or in clinical procedures. We do not plan to be present at any research sites in person, though may perform monitoring visits if funds are available.
- Conditions
- Contraception, Maternal Care Patterns, Pregnancy Related
- Being tested
- Counseling and provision of contraception
- Keywords
- intrauterine device, postpartum contraception, repeat pregnancy, adolescent pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling and provision of contraceptionOther
Also called Copper IUD, Jadelle
Provider training, availability of contraceptive methods
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women receiving immediate postpartum long-acting contraception
The proportion of women who receive immediate long-acting contraception prior to hospital discharge following the intervention phase of training and availability of devices will be compared to a baseline group prior to the implementation.
Measured: Through hospital discharge (an average of 3 days)
Secondary outcomes (3)
Continuation of long-acting contraception placed immediately postpartum
Phone followup will be used to determine the proportion of women who are continuing their contraceptive method
Measured: 6, 12 and 18 months postpartum
Complications of contraception
Phone followup will be used to determine the proportion of women who have experienced any complications from contraception
Measured: 6, 12 and 18 months postpartum
Comparison of long-acting methods to short-acting methods
Outcomes (pregnancy, discontinuation) of women choosing long-acting methods will be compared to short-acting methods, coital dependent methods, or no method
Measured: 6, 12, and 18 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start1 Oct 2015
- Primary completion30 Dec 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Antioquia
- Responsible party
- Principal investigator, Maureen Baldwin, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389958
- Sponsor's protocol ID
- 11331
- Acronym
- COMSE
- Status last verified
- Dec 2017
- First submitted
- 20 Dec 2017
- Last updated
- 4 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception
- ClinicalTrials.gov ID
- NCT03389958
- Acronym / sponsor ID
- COMSE / 11331
- Conditions
- Contraception, Maternal Care Patterns, Pregnancy Related
- Keywords
- intrauterine device, postpartum contraception, repeat pregnancy, adolescent pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Universidad de Antioquia
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 4 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter observational study of implementation of postpartum contraceptive counseling and provision into the maternity care setting in Colombia, South America. The primary aim is to determine proportion of uptake of highly-effective contraceptive use after these methods become available immediately postpartum. Secondary aims include rapid repeat pregnancy rates, use of other types of contraception, breastfeeding continuation, and visualization of IUD strings after immediate postpartum placement.
Detailed description
This pre- post-intervention study will take place in Colombia, South America in 2 cities: Medellin (2 sites and Cartagena 1 site). The main objective is to determine the proportion of contraceptive usage by women who have just had a baby, before and after the introduction of specialized contraceptive counseling into maternity care and availability of the most effective contraceptive methods:
Group 1 (Standard of care) participants will be asked about intention for contraception usage upon hospital discharge after maternity care.
Group 2 (Intervention) participants will receive standardized contraceptive counseling and immediate access to the method of choice, including long acting reversible contraception (LARC) and other locally available methods. LARC methods available in Colombia include the copper-T intrauterine device (IUD) and Jadelle® implant, both of which are safe for usage in postpartum women.
Both groups will undergo follow- up via phone at 6-8 weeks, and 6 and 12 months postpartum to determine contraceptive continuation, repeat pregnancy, and to track any complications with the usage of LARC, including infection and contraceptive failure. For subjects with an IUD, an additional visit would take place at 8-10 days to determine need for IUD string trimming and visualization of strings.
The intervention will include introduction of specialized standardized contraceptive counseling to occur during inpatient maternity care and immediate postpartum availability of LARC methods. Currently, contraceptive counseling is left to the postpartum primary care setting and obstetric providers are not trained for immediate IUD placement. LARC devices are not typically available in the inpatient setting. Providers and staff of all levels will be trained in standardized contraceptive counseling methods. Obstetric providers will be trained in immediate postplacental IUD insertion. Staff nurses and providers will have access to company-sponsored implant insertion training programs.
The proportion of participants using LARC methods after implementation of the intervention will be compared to the proportion choosing LARC prior to the intervention. Additionally, the outcomes of women choosing non-LARC methods will be compared to those choosing LARC methods.
The study has received funding by the Colombian grant agency, Colciencias. Regulatory oversight has previously been granted by the University of Antioquia's (Medellin, Colombia) Institutional Review Board. Research operations are managed by the local Colombian organization, NACER, with support of research design and methods, statistical analysis, and medical expertise and trainings provided by clinicians from OHSU. Day to day research operations will be managed by research coordinators at each of the three maternity care hospital sites with support and monitoring by NACER and by OHSU clinicians.
The role of OHSU clinicians will be to provide research infrastructure and clinical support via remote communications, to provide initial training of trainers, to provide monitoring of recruitment and counseling methods, to help in the creation and monitor quality of data collection forms, and to perform statistical analyses. OHSU will not participate in recruitment of participants or in clinical procedures. We do not plan to be present at any research sites in person, though may perform monitoring visits if funds are available.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing management of a pregnancy that results in live birth over 20 weeks gestation during the same hospitalization at three public hospitals in Colombia (in Cartagena and Medellin).
Key inclusion criteria (3 listed)
- Pregnant woman in labor
- Live fetus over 20 weeks gestation
- Age >14 years
Key exclusion criteria (1 listed)
- No medical exclusions for the contraceptive method chosen
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 |
|---|---|---|
| Counseling and provision of contraceptionAlso: Copper IUD, JadelleProvider training, availability of contraceptive methods | Other | – |
Primary outcome
Proportion of women receiving immediate postpartum long-acting contraception
Time frame: Through hospital discharge (an average of 3 days)
The proportion of women who receive immediate long-acting contraception prior to hospital discharge following the intervention phase of training and availability of devices will be compared to a baseline group prior to the implementation.
3 secondary outcomes
Continuation of long-acting contraception placed immediately postpartum
Time frame: 6, 12 and 18 months postpartum
Complications of contraception
Time frame: 6, 12 and 18 months postpartum
Comparison of long-acting methods to short-acting methods
Time frame: 6, 12, and 18 months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Maternal Care Patterns, run by Oregon Health and Science University at 3 sites in Colombia.
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 3 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of women receiving immediate postpartum long-acting contraception (time frame: Through hospital discharge (an average of 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2018.