Optimizing Postpartum Contraception in Women With Preterm Births

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Postpartum Contraception in Women With Preterm Births

Conditions
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Method of Contraception, Preterm Birth Recurrence

Intervention / Treatment
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* Behavioral: Focused contraception counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Contraception after preterm birth<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>Participants will receive the standard postpartum contraception counseling that is received by all patients who deliver at our institution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of highly effective method |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcomes |  | 12 months, 18 months, 24 months, 36 months | 
| Use of highly effective method |  | 12 months, 24 months, 36 months |