NCT03165838

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2017

Completed
Last Updated

August 17, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

May 8, 2017

Last Update Submit

August 14, 2017

Conditions

Pregnancy RelatedContraceptionContraception BehaviorContraception Use

Keywords

postpartumpregnancycontraceptionRROP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Contraception Use

    Assessed at 3, 6, 9, 12, & 18 month follow-ups

  • Rapid Repeat Pregnancy

    Assessed at 3, 6, 9, 12, & 18 month follow-ups

  • Cost effectiveness

    18 month postpartum

Other Outcomes (1)

  • Racial Differences

    baseline, postpartum, 3, 6, 9, 12, & 18 month follow-ups

Study Arms (2)

Postpartum Visit 3-4 Weeks

EXPERIMENTAL

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

Behavioral: Postpartum Visit 3-4 Weeks

Postpartum Visit 6-8 Weeks

EXPERIMENTAL

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

Behavioral: Postpartum Visit 6-8 Weeks

Interventions

Postpartum Visit 3-4 WeeksBEHAVIORAL

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

Postpartum Visit 3-4 Weeks
Postpartum Visit 6-8 WeeksBEHAVIORAL

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

Also known as: Standard of Care
Postpartum Visit 6-8 Weeks

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 34286512DERIVED

  • 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.

    PMID: 31004814DERIVED

MeSH Terms

Conditions

Contraception Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Saba W Masho

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 24, 2017

Study Start

November 18, 2013

Primary Completion

March 3, 2016

Study Completion

June 20, 2017

Last Updated

August 17, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share