Co-Scheduled Newborn and Contraception Care for Postpartum Women

(LINCC Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to simplify access to contraception for postpartum women by aligning it with their baby's well-baby checkups. The goal is to reduce pregnancies within 18 months of a previous birth, which can pose risks to both mother and child. The trial will evaluate whether this combined scheduling approach, known as the LINCC intervention, enhances contraception use among new mothers. Women who recently gave birth and visit certain clinics for their baby's first checkup are ideal candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could streamline postpartum care and improve health outcomes.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on postpartum contraception care, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this co-scheduling method is safe for postpartum women?

Research has shown that combining postpartum care with newborn visits can increase the likelihood of women obtaining contraception after childbirth. The LINCC intervention aims to simplify access to birth control by aligning it with their baby's doctor visits.

Specific safety data for this scheduling feature is not available, as it enhances healthcare access rather than serving as a medical treatment. However, it is generally considered safe since it utilizes existing medical practices. The primary goal is to help women avoid closely spaced pregnancies, which can pose risks for both mother and baby.

Overall, this approach supports women without introducing new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to postpartum care by integrating newborn and contraception appointments. Unlike traditional methods where appointments for postpartum contraception are scheduled separately from pediatric visits, this co-scheduling method aims to streamline care. By using electronic medical records to flag eligible women and pre-scheduling appointments during well-baby visits, it reduces the chances of missed contraception care. This innovative strategy could improve access to postpartum contraceptive services and enhance overall healthcare efficiency for new mothers.

What evidence suggests that the LINCC intervention is effective for improving postpartum contraception access?

Research has shown that the LINCC program, tested in this trial, schedules birth control care alongside newborn check-ups, making contraception more accessible for new mothers. Participants in the intervention arm will experience this co-scheduling approach. Studies have found that this method increases the use of effective birth control methods within two months after childbirth. This approach is particularly helpful in preventing pregnancies occurring less than 18 months after a previous birth, which can pose health risks. The program simplifies access to birth control by integrating it with the baby's regular doctor visits. This combined care method has proven more effective than usual care in helping new mothers use contraception after childbirth. ^{1 3 5 6 7}

Who Is on the Research Team?

Sadia Haider, MD

Principal Investigator

Rush University Medical Center

Rachel Caskey, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive co-scheduled postpartum contraception and newborn care visits

6 months

Visits co-scheduled with well-baby visits

Follow-up

Participants are monitored for receipt of contraception and short inter-pregnancy interval pregnancies

24 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12419694/

Linking Inter-professional Newborn and Contraception Care ... The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04092530

Linking Inter-professional Newborn and Contraception Care Low rates of postpartum contraception uptake leave women vulnerable to an unplanned pregnancy and significant negative health consequences. Thus, there is an ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39121991/

Protocol for a stepped wedge cluster randomized trial to ... The LINCC Trial seeks to evaluate the effectiveness and feasibility of a linked care model in comparison to usual care.

4. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=4801768

Linking Inter-Professional Newborn and Contraception ... The primary outcome of this study is receipt of most or moderately effective methods of contraception by two months PP. Secondary outcomes ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/30/NCT04092530/Prot_SAP_000.pdf

Linking Inter-professional Newborn and Contraception Care ( ... Expected Outcomes. Intervention: After the intervention period begins, postpartum women within the selected. CHC sites will be more likely to receive any ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002428

Linking Inter-professional Newborn and Contraception ... The outcomes of the study include receipt of most or moderately effective methods of contraception by two and six months PP; and rate of short IPI pregnancies.

7. papers.ssrn.com papers.ssrn.com/sol3/Delivery.cfm/ae461360-79a5-4daa-bf84-a55d13a81af7-MECA.pdf?abstractid=4801768&mirid=1

Linking Inter-professional Newborn and Contraception Care ( ... identifies PP women eligible for LINCC. The LINCC Trial intervention will be implemented as a. 195 system-level intervention at each participating site. 196.