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Labor and Delivery Implant Insertion: A Randomized Controlled Trial (LADII)

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ClinicalTrials.gov Identifier: NCT02866643
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Kate Ayers Shaw, Stanford University

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 add to safety data on 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).

Condition or disease Intervention/treatment Phase
Postpartum Contraception Family Planning Drug: Etonogestrel-Immediate Drug: Etonogestrel-Delayed Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Labor and Delivery Implant Insertion: A Randomized Controlled Trial
Actual Study Start Date : October 28, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Delivery Room Insertion
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
The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
Other Names:
  • Nexplanon
  • Contraceptive Implant

Active Comparator: Postpartum Insertion
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
The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
Other Names:
  • Nexplanon
  • Contraceptive Implant




Primary Outcome Measures :
  1. Time to Lactogenesis Stage II [Questionnaire] [ Time Frame: 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. ]

    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.



Secondary Outcome Measures :
  1. Breastfeeding continuation and exclusivity [Questionnaire] [ Time Frame: The investigators will administer a questionnaire using Redcap (TM) software at 4-8 weeks, 3, 6, and 12 months following insertion of contraceptive implant. ]
    The questionnaire will ask questions about breastfeeding continuation, supplementation, duration, and exclusivity. This questionnaire will also include questions about contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

  2. Contraceptive continuation [Questionnaire] [ Time Frame: The investigators will administer a questionnaire using Redcap (TM) software at 4-8 weeks, 3, 6, and 12 months following insertion of contraceptive implant. ]
    The questionnaire will ask questions about contraceptive continuation with the implant and other forms of contraception. This questionnaire will also include questions about breastfeeding continuation, supplementation, duration, and exclusivity, contraceptive continuation, patient satisfaction with implant, pregnancy, and postpartum care visits.

  3. Patient satisfaction with choice of implant as form of postpartum contraception [Questionnaire] [ Time Frame: The investigators will administer a questionnaire using Redcap (TM) software at 4-8 weeks, 3, 6, and 12 months following insertion of contraceptive implant. ]
    The questionnaire will ask questions about patient satisfaction with use of the implant. This questionnaire will also include questions about breastfeeding continuation, supplementation, duration, and exclusivity, contraceptive continuation,pregnancy, and postpartum care visits.

  4. Pregnancy rates [Questionnaire] [ Time Frame: The investigators will administer a questionnaire using Redcap (TM) software at 4-8 weeks, 3, 6, and 12 months following insertion of contraceptive implant. ]
    The questionnaire will ask questions about subsequent pregnancy. This questionnaire will also include questions about breastfeeding continuation, supplementation, duration, and exclusivity, contraceptive continuation, patient satisfaction with implant, and postpartum care visits.

  5. Postpartum care visits [Questionnaire] [ Time Frame: The investigators will administer a questionnaire using Redcap (TM) software at 4-8 weeks, 3, 6, and 12 months following insertion of contraceptive implant. ]
    The questionnaire will ask questions about postpartum care visits. This questionnaire will also include questions about breastfeeding continuation, supplementation, duration, and exclusivity, contraceptive continuation, patient satisfaction with implant, and pregnancy.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy pregnant women
  • Intend to breastfeed
  • Desire the contraceptive implant as their method of contraception
  • Agree to be randomized to delivery room vs. postpartum ward insertion
  • Have delivered a healthy term infant (37 weeks gestation)

Exclusion Criteria:

  • Not English or Spanish speaking
  • Allergy or Contraindication to contraceptive implant.

Information from the National Library of Medicine

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): NCT02866643


Contacts
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Contact: Kate A Shaw, MD, MS 650-721-1562 fpresearch@stanford.edu
Contact: Klaira Lerma, MPH 65072111 fpresearch@stanford.edu

Locations
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United States, California
Obstetrics--Lucile Packard Children's Hospital Recruiting
Stanford, California, United States, 94305
Contact: Klaira M Lerma, MPH    650-721-1562    fpresearch@stanford.edu   
Principal Investigator: Kate A Shaw, MD, MS         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kate A Shaw, MD, MS Stanford University

Publications:

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Responsible Party: Kate Ayers Shaw, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02866643     History of Changes
Other Study ID Numbers: IRB-38505
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kate Ayers Shaw, Stanford University:
contraceptive implant
postpartum contraception
breastfeeding and contraception

Additional relevant MeSH terms:
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Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists