Maternity Care and Contraception

Pregnancy Related Clinical Trial

— COMSE  

Official title:

Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389958
• Other study ID #: 11331
• Status: Completed
• Phase: N/A
• First received: December 20, 2017
• Last updated: December 27, 2017
• Start date: October 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: December 2017
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: April 1, 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant woman in labor

• Live fetus over 20 weeks gestation

• Age >14 years

Exclusion Criteria:

• No medical exclusions for the contraceptive method chosen

Related Conditions & MeSH terms

• Contraception
• Maternal Care Patterns
• Pregnancy Related

Intervention

Other:
• Counseling and provision of contraception
Provider training, availability of contraceptive methods

Locations

Country	Name	City	State
Colombia	Maternidad Rafael Calvo	Cartagena
Colombia	Hospital General de Medellin	Medellín
Colombia	Metrosalud Manrique	Medellín

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Universidad de Antioquia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through hospital discharge (an average of 3 days)
Secondary	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	6, 12 and 18 months postpartum
Secondary	Complications of contraception	Phone followup will be used to determine the proportion of women who have experienced any complications from contraception	6, 12 and 18 months postpartum
Secondary	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	6, 12, and 18 months postpartum