Co-Scheduled Newborn and Contraception Care for Postpartum Women

(LINCC Trial)

Recruiting at 4 trial locations

Overseen By Emily Ott, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Tubal ligation, Emergency hysterectomy, Male, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2518 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sadia Haider, MD

Principal Investigator

Rush University Medical Center

Rachel Caskey, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for women who have recently given birth and are visiting one of the selected 7 CHC sites with their infants for the first well-baby visit, typically 3-5 days post-delivery. It's not open to men, or women who had tubal ligation or planned long-term birth control right after delivery, nor those who needed an emergency hysterectomy.

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

I have not had an emergency hysterectomy due to bleeding during delivery.

I am not eligible for the study as it is only for female patients.

I have not had a tubal ligation or plan to use long-term birth control right after giving birth.

Treatment Details

Interventions

• LINCC intervention - enable co-schedule feature

Trial Overview The study is testing a new approach called LINCC intervention that links postpartum contraception care with newborn baby care by scheduling them together. The goal is to improve access to timely postpartum contraception and reduce health risks associated with pregnancies occurring close together.

Participant Groups

Group I: Intervention - Aim 2 Experimental Treatment 1 Intervention

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.

Group II: Control - Aim 2 Active Control 1 Intervention

Clinics will schedule postpartum contraception using normal clinic procedures.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

AllianceChicago

Collaborator

Trials

8

Recruited

18,700+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+