Labor and Delivery Implant Insertion: A Randomized Controlled Trial

Study Overview
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Brief Summary
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A barrier to initiating progestin contraceptives in the early postpartum period is the concern of interference with breastfeeding, specifically lactogenesis. In this trial, the investigators aim to describe the effects of immediate insertion of the contraceptive implant on breastfeeding. The investigators seek to examine the time to lactogenesis with immediate post-delivery insertion in delivery room versus insertion of a contraceptive implant in the postpartum ward prior to medical discharge. For this study, 82 consenting women will be randomized to immediate implant insertion (0-2 hours following delivery) in the delivery room or insertion of the implant following delivery in postpartum room and prior to medical discharge (24-48 hours following delivery). Participants complete a questionnaire that asks questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire also includes questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

Official Title
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Labor and Delivery Implant Insertion: A Randomized Controlled Trial

Conditions
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Postpartum Contraception, Family Planning

Intervention / Treatment
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* Drug: Etonogestrel-Immediate
* Drug: Etonogestrel-Delayed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who are patients of the Stanford University Obstetrics service Pregnant women who delivery a healthy infant, regardless of gestational age. Intend to breastfeed Desire the contraceptive implant as their method of contraception Agree to be randomized to delivery room vs. postpartum ward insertion Exclusion Criteria: Not English or Spanish speaking Allergy or Contraindication to contraceptive implant.
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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delivery Room Insertion<br>Participants who randomize to this arm will receive the contraceptive implant in the Labor and Delivery room (0-2 hours following delivery). | Drug: Etonogestrel-Immediate<br>* The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).<br>* Other names: Contraceptive Implant;|
| Active Comparator: Postpartum Insertion<br>Participants who randomize to this arm will receive the contraceptive implant in the postpartum ward room before discharge (24-48 hours following delivery). | Drug: Etonogestrel-Delayed<br>* The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.<br>* Other names: Contraceptive Implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Lactogenesis Stage II [Questionnaire] | Lactogenesis Stage II: The initiation of copious milk secretion as documented by maternal perception. To obtain measurement of time to lactogenesis, we will document time at which participants perceive initiation of copious milk secretion using a set of specific validated questions and subtract this by the documented time of delivery. | Participants will be monitored daily by the research staff, in the first seven days postpartum, or until lactogenesis reported, beginning at 24-hours following delivery, to determine time to lactogenesis stage II. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of of Participants Actively Breastfeeding | Exclusive breastfeeding means feedling with breast milk only. Any breast feeding means feeding with breast milk, with water and/or formula. | 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery | 
| Number of Participants Still With the Contraceptive Implant at Month 12. |  | month 12 | 
| Number of Participants Satisfied or Very Satisfied With Implant Contraceptive | Participant-rated as very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied, or very dissatisfied. | month 12 | 
| Number of Participants Reporting a Pregnancy Within 12 Months |  | 12 months | 
| Number of Participants Attending a Postpartum Care Visit by Month 3 |  | month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptive implant, postpartum contraception, breastfeeding and contraception