Clinical Trials Directory

Trials / Completed

CompletedNCT04092530

Linking Inter-professional Newborn and Contraception Care

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,518 (actual)
Sponsor
Rush University Medical Center · Academic / Other
Sex
Female
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALLINCC intervention - enable co-schedule featureClinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit

Timeline

Start date
2021-04-01
Primary completion
2023-06-30
Completion
2024-06-30
First posted
2019-09-17
Last updated
2025-09-04
Results posted
2025-09-04

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT04092530. Inclusion in this directory is not an endorsement.