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OpenTrials
Completed

NCT Number: NCT01864629

Optimizing Postpartum Contraception in Women With Preterm Births

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.

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Key information

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Focused contraception counseling

Behavioral

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.

Primary outcomes

  1. Use of highly effective method

    Time frame: Three months

Secondary outcomes

  1. Pregnancy outcomes

    Time frame: 12 months, 18 months, 24 months, 36 months

  2. Use of highly effective method

    Time frame: 12 months, 24 months, 36 months

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
May 29, 2013
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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