Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04092530 |
| Other study ID # |
1R01HD097171 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
February 21, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Rush University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
