Pregnancy Related Clinical Trial
— COMSEOfficial title:
Safe Maternity Care Through Immediate Provision of Highly-effective Postpartum Contraception
Verified date | December 2017 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Colombia | Maternidad Rafael Calvo | Cartagena | |
Colombia | Hospital General de Medellin | Medellín | |
Colombia | Metrosalud Manrique | Medellín |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | Universidad de Antioquia |
Colombia,
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 |
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