Clinical trial NCT02866643: Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Official title: Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Contraception
Family Planning
Keywords: contraceptive implant
postpartum contraception
breastfeeding and contraception
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 95
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to Lactogenesis Stage II [Questionnaire]
timeFrame: 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 outcomes:
measure: Number of of Participants Actively Breastfeeding
timeFrame: 2 weeks, 4 weeks, 3 months, 6 months, and 12 months after delivery
measure: Number of Participants Still With the Contraceptive Implant at Month 12.
timeFrame: month 12
measure: Number of Participants Satisfied or Very Satisfied With Implant Contraceptive
timeFrame: month 12
measure: Number of Participants Reporting a Pregnancy Within 12 Months
timeFrame: 12 months
measure: Number of Participants Attending a Postpartum Care Visit by Month 3
timeFrame: month 3
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Obstetrics--Lucile Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Kate A Shaw, MD, MS
role: PRINCIPAL_INVESTIGATOR
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