Overview

This trial is active, not recruiting.

Conditions method of contraception, preterm birth recurrence
Treatment focused contraception counseling
Sponsor University of Utah
Start date April 2013
End date October 2014
Trial size 362 participants
Trial identifier NCT01864629, IRB_00061119

Summary

The purpose of this study is to examine the effectiveness of focused family planning counseling on the uptake and continuation of highly effective contraceptive methods (defined as the intrauterine device, implant, and both male and female sterilization methods including vasectomy, tubal ligation and Essure) during the postpartum period in women who have recently experienced a preterm delivery.

The investigators hypothesize that women with a recent preterm birth (PTB) will be more likely to initiate and continue using a highly effective method of contraception when provided with focused family planning counseling.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Other)
Intervention name: Focused contraception counseling This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.
focused contraception counseling
This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.
(No Intervention)
Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.

Primary Outcomes

Measure
Use of highly effective method
time frame: Three months

Secondary Outcomes

Measure
Pregnancy outcomes
time frame: 12 months, 18 months, 24 months, 36 months
Use of highly effective method
time frame: 12 months, 24 months, 36 months

Eligibility Criteria

Female participants from 14 years up to 50 years old.

Inclusion Criteria: - Women who deliver a premature infant that is between the gestational ages of 24 weeks 0 days and 36 weeks 6 days at our institution. Exclusion Criteria: - Women who have delivered via cesarean section and have also had a sterilization procedure at the time of the cesarean section.

Additional Information

Official title Optimizing Postpartum Contraception in Women With Preterm Births
Principal investigator David K Turok, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Utah.