Linking Inter-professional Newborn and Contraception Care

NCT04092530 | Completed Results

• 1 other identifier: 1R01HD097171
• Study Type: interventional
• Target: 2,518
• Locations: 1 country
• Sites: 5

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.

Conditions

Family Planning; Contraception; PostPartum

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Receive Contraception by Two Months Postpartum

  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

  2 months

Secondary Outcomes (2)

• Number of Patients Who Receive Contraception by Six Months Postpartum

  6 months

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

  12 months

Study Arms (2)

Intervention - Aim 2

EXPERIMENTAL

During the intervention period, staff will capture women during the first well-baby visit (WBV) and offer to have the next visit co-scheduled for infant and contraception care. Appointments are scheduled during the discharge process at the end of each WBV. During the discharge process all women 0-6 months postpartum will be identified by clerical staff through review of each pediatric clinic beforehand and through an electronic flag alert in the infant's electronic medical record. The pre-review of pediatric clinic schedules and the use of the flag will remind staff to offer the mother a co-scheduled visit for newborn and contraceptive care at the time of the next newborn visit.

Behavioral: LINCC intervention - enable co-schedule feature

Control - Aim 2

NO INTERVENTION

Clinics will schedule postpartum contraception using normal clinic procedures.

Interventions

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

Intervention - Aim 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead
• University of Illinois at Chicago: collaborator
• AllianceChicago: collaborator

Study Sites (5)

Malama O ke Ola

Wailuku, Hawaii, 96793, United States

Location

Friend Health

Chicago, Illinois, 60615, United States

Location

Heartland Health Centers

Chicago, Illinois, 60640, United States

Location

Infant Welfare Society

Chicago, Illinois, 60647, United States

Location

Settlement Health

New York, New York, 10029, United States

Location

Results Point of Contact

• Title: Kristin Rankin
• Organization: University of Illinois at Chicago

krankin@uic.edu

708-710-8411

Study Officials

• Sadia Haider, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Rachel Caskey, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Effectiveness-Implementation Hybrid Design

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 17, 2019
• Study Start: April 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: September 4, 2025
• Results First Posted: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)