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

NCT ID: NCT03165838

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 364 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-18
• Study Completion Date: 2017-06-20

Brief Summary

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.

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.

Conditions

Pregnancy Related; Contraception; Contraception Behavior; Contraception Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Postpartum Visit 3-4 Weeks

Participants will have postpartum visit scheduled 3-4 weeks after birth

Group Type: EXPERIMENTAL

Postpartum Visit 3-4 Weeks

Intervention Type: BEHAVIORAL

This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.

Postpartum Visit 6-8 Weeks

Participants will have postpartum visit scheduled 6-8 weeks after birth

Group Type: EXPERIMENTAL

Postpartum Visit 6-8 Weeks

Intervention Type: BEHAVIORAL

This standard of care postpartum visit will be scheduled for the standard time interval.

Interventions

Postpartum Visit 3-4 Weeks

This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.

Intervention Type: BEHAVIORAL

Postpartum Visit 6-8 Weeks

This standard of care postpartum visit will be scheduled for the standard time interval.

Intervention Type: BEHAVIORAL

Other Intervention Names

Standard of Care

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saba W Masho

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

References

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.

Reference Type: DERIVED

PMID: 34286512 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31004814 (View on PubMed)

Other Identifiers

HM20000032

Identifier Type: -

Identifier Source: org_study_id