Effectiveness of Shortened Time Interval to Postpartum Visit in Improving Postpartum Attendance

Due to potential to improve family planning, clinicians are increasingly interested in shortening the time to postpartum visits, but lack an evidence base to change policy.There are no studies that have examined the effectiveness of shortened interval to postpartum visit on attendance rate, contraception use, and rapid repeat of pregnancy (RROP). With this research, the investigators propose to conduct a randomized controlled trial (RCT) to examine the effect of reduced time interval to postpartum visit (3-4 weeks rather than 6-8 weeks) on postpartum visit attendance rate, contraceptive use, and RROP.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Contraception; Contraception Behavior; Contraception Use
• Intervention / Treatment: Behavioral: Postpartum Visit 3-4 Weeks; Behavioral: Postpartum Visit 6-8 Weeks

Detailed Description

Postpartum care is an essential component of women's reproductive health. During this time, the health care provider and the new mother review the previous pregnancy course, assess the mother's wellbeing, and establish treatment plans for any ongoing problems. Prospective guidance is given for both the mother and the baby in areas such as breastfeeding, nutrition, depression screening, and perineal/vulvar care. However, one of the most important goals of the postpartum visit is to discuss the new mother's desire for future pregnancies and the interval she wishes before another pregnancy. Inadequate reproductive health planning may result in unintended or rapid repeat of pregnancy (RROP), clinically defined as a second pregnancy within 24 months of the end of a previous pregnancy. A short inter-pregnancy interval is a risk factor for poor pregnancy outcomes including stillbirth, early neonatal death, extreme preterm births, and babies born small for gestational age. Compared to women who conceived 18-23 months after a previous birth, women conceiving less than five months after a previous birth had increased third trimester bleeding, uterine infection, premature rupture of membranes, and maternal death.Central to these outcomes is the rate of postpartum contraception use.

In fact, research shows an association between a postpartum visit and use of a reliable contraceptive method after pregnancy.

The optimal time for postpartum visit may be 3-4 weeks post-delivery rather than 6-8 weeks post-delivery with regard to visit attendance and proactive management of reproductive health, including contraception and time intervals between pregnancies. The timing of the postpartum visits are also linked to economic outcomes and healthcare utilization; postpartum care that results in decreased RROP and unintended pregnancies will likely decrease healthcare costs associated with the adverse consequences of inadequate reproductive health planning. Despite the obvious potential benefits of a decreased interval between delivery and the postpartum visit, to date, there have been no studies to systematically compare the impact of postpartum visit timing on visit attendance, contraception use and, subsequently, RROP.

This study is designed to investigate the effect of reduced time interval to postpartum visit on postpartum visit attendance rate, contraceptive use, and RROP. Additionally, the study will assess the impact of the two visit schedules on these outcomes by race, providing critical information about high risk populations. Finally, this research will assess the cost effectiveness of the shortened postpartum visit schedule relative to the standard of care. In order to account for potential bias in increased attendance rate due to intervention effect, compensation and other factors, this study will also compare the effectiveness of shortened time interval to postpartum visit on postpartum attendance rate and contraceptive use to a historic cohort.

• Study Type: Interventional
• Enrollment (Actual): 364
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• at least 18 years of age
• delivered vaginally a healthy, full-term (at least 37 weeks gestation) baby
• received prenatal care services at the VCUMCV OB clinic
• speak English
• provide informed consent for study participation.

Exclusion Criteria:

• cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent
• surgically sterilized
• have complicated deliveries that require extended hospital stays
• need early follow-up to monitor their conditions
• any problems with infants such as preterm birth, admission to the Neonatal Intensive Care Unit (NICU), congenital malformations or respiratory problems that would require frequent clinic visits or prolonged hospital admissions for the infants.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postpartum Visit 3-4 Weeks; Participants will have postpartum visit scheduled 3-4 weeks after birth	Behavioral: Postpartum Visit 3-4 Weeks; This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.
Experimental: Postpartum Visit 6-8 Weeks; Participants will have postpartum visit scheduled 6-8 weeks after birth	Behavioral: Postpartum Visit 6-8 Weeks; This standard of care postpartum visit will be scheduled for the standard time interval.; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum Clinic Attendance	To compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on improving the rate of postpartum visit attendance. The investigators hypothesize that study participants with postpartum visits scheduled 3-4 weeks after delivery will be more likely to attend visits than study participants scheduled for visits 6-8 weeks after delivery.	assessed at 12 weeks postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraception Use	Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on consistent contraceptive use	Assessed at 3, 6, 9, 12, & 18 month follow-ups
Rapid Repeat Pregnancy	Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on repeat pregnancy	Assessed at 3, 6, 9, 12, & 18 month follow-ups
Cost effectiveness	Compare overall cost of postpartum care	18 month postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Racial Differences	Compare the effectiveness of 3-4 week and 6-8 week intervals to postpartum visit on reducing racial differences in postpartum visit attendance rates and contraceptive use. Specifically, the study team hypothesizes that the difference in postpartum visit attendance and consistent contraceptive use rates between AA and CA study participants will be lower among study participants with postpartum visits scheduled 3-4 weeks after delivery compared to study participants scheduled for visits 6-8 weeks after delivery.	baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Saba W Masho, Virginia Commonwealth University

Publications and helpful links

General Publications

• Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.
• Masho SW, Ihongbe TO, Wan W, Graves WC, Karjane N, Dillon P, Bazzoli G, McGee E. Effectiveness of shortened time interval to postpartum visit in improving postpartum attendance: Design and rationale for a randomized controlled trial. Contemp Clin Trials. 2019 Jun;81:40-43. doi: 10.1016/j.cct.2019.04.012. Epub 2019 Apr 18.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2013
• Primary Completion (Actual): March 3, 2016
• Study Completion (Actual): June 20, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: pregnancy; contraception; postpartum; RROP
• Other Study ID Numbers: HM20000032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No