Linking Inter-professional Newborn and Contraception Care

Not Applicable

Completed

• Conditions: Family Planning; Contraception; PostPartum

• Registration Number: NCT04092530
• Lead Sponsor: Rush University Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-17
• Study Start: 2021-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30
• Results First Submitted: 2025-06-18
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Results First Posted: 2025-09-04
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2518

Inclusion Criteria

• Eligible participants include women presenting with their infants at one of the 7 chosen CHC sites for their first WBV (typically 3-5 days after delivery).

Exclusion Criteria

• Women will be excluded if they had a tubal ligation or a long acting reversible contraception planned immediately after delivery. Additionally, women will be excluded if they needed an emergency hysterectomy due to life threatening bleeding during delivery. Any male patients will be excluded from the study because the study outcomes of contraceptive method use and pregnancy status are not applicable to males.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Receive Contraception by Two Months Postpartum	2 months	Using de-identified patient data collected through clinic's Electronic Health Record (EHR) system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by two months postpartum

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Receive Contraception by Six Months Postpartum	6 months	Using de-identified patient data collected through clinic's Electronic Medical Record system (i.e., visit type attended, billing codes for contraception) we will measure receipt of all methods of contraception by six months postpartum
Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies	12 months	Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum)

Trial Locations

Locations (5)

Malama O ke Ola; 🇺🇸 Wailuku, Hawaii, United States

Friend Health; 🇺🇸 Chicago, Illinois, United States

Heartland Health Centers; 🇺🇸 Chicago, Illinois, United States

Infant Welfare Society; 🇺🇸 Chicago, Illinois, United States

Settlement Health; 🇺🇸 New York, New York, United States