Optimizing Postpartum Contraception in Women With Preterm Births
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|ClinicalTrials.gov Identifier: NCT01864629|
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : October 26, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Method of Contraception Preterm Birth Recurrence||Behavioral: Focused contraception counseling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimizing Postpartum Contraception in Women With Preterm Births|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||January 2016|
Contraception after preterm birth
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.
Behavioral: 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: Control Group
Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution.
- Use of highly effective method [ Time Frame: Three months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864629
|United States, Utah|
|University of Utah Hospital|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||David K Turok, MD||University of Utah|