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Completed

NCT Number: NCT04092530

Linking Inter-professional Newborn and Contraception Care

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malama O ke Ola, Wailuku, Hawaii, United States

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About this study

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:

  • develop a comprehensive implementation plan to link PP contraception and newborn care through co-scheduling visits in community health centers (CHC);
  • 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;
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LINCC intervention - enable co-schedule feature

Behavioral

Clinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit

Primary outcomes

  1. Number of Patients Who Receive Contraception by Two Months Postpartum

    Time frame: 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 outcomes

  1. Number of Patients Who Receive Contraception by Six Months Postpartum

    Time frame: 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

  2. Number of Patients Who Present With a Short Inter-pregnancy Interval Pregnancies

    Time frame: 12 months

    Use EHR data to follow up participants for short IPI (subsequent pregnancy before 12 months postpartum)

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • AllianceChicago
  • University of Illinois at Chicago

Registry information

Official study title

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

Acronym: LINCC

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 17, 2019
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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