Breastfeeding Etonogestrel Implant Study (LACTO-Rod)

December 18, 2023 updated by: University of New Mexico

Effect of Immediate Versus Standard Postpartum Insertion of the Contraceptive Implant on Breastfeeding Outcomes

The investigators are studying the effect of placing the etonogestrel implant (Nexplanon) in the first 24 hours after birth on breastfeeding. Women who wish to have an etonogestrel implant placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the implant placed in the first 24 hours after delivery of the baby and placenta or 4-6 weeks later. The investigators do not believe there will be a difference in breastfeeding 8 weeks after delivery or time to lactogenesis between those who get the implant placed early or later.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Counseling and provision of postpartum contraception is an integral component of comprehensive reproductive healthcare. A woman's preference for contraception is paramount; early initiation of postpartum contraception may assist in optimal birth spacing promoting the wellbeing of mother and baby. Equally important is the provision of appropriate support for breastfeeding. Exclusive breastfeeding for six months with continuation beyond one year of age is recommended by the American Academy of Pediatrics (AAP), American Academy of Family Physicians, American College of Obstetricians and Gynecologists (ACOG), and the World Health Organization (WHO).

The utilization of Long Acting Reversible Contraception (LARC's) has increased in the last decade. The etonogestrel (ENG) implant is one of the most effective LARC's and has become one of the methods used by many women in the postpartum period to prevent an unplanned pregnancy. The major advantage of immediate ENG implant insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with breastfeeding and the life changes and demands of motherhood.

Our long-term goal is to understand the impact of the ENG implant hormonal contraceptive, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that breastfeeding continuation at eight weeks postpartum is not inferior in women in the immediate insertion group of the ENG implant than in those with standard insertion and that time to lactogenesis stage II is not more than 8 hours difference between the immediate insertion and standard insertion groups.

Primary:

Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups.

Aim #2: To determine the timing of lactogenesis in both groups

Secondary:

Aim #1: To assess breastfeeding continuation and exclusivity between the immediate versus the standard group. Aim #2: To compare postpartum factors associated with discontinuing breastfeeding between the immediate versus the standard group. Aim #3: To compare participant satisfaction with postpartum contraception counseling in women enrolled in the study and in those women who opted not to enroll in the study between the immediate versus the standard group. Aim #4: To compare postpartum mood as measured by EPDS score between the immediate versus the standard group. Aim #5: To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score between the immediate versus the standard group. Aim #6: To compare the total number of days of postpartum bleeding in the immediate versus standard. Aim #7: To compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group

This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate insertion (first 24 hours after delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the ENG implant.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnant women or women who have delivered vaginally and by cesarean section within 22 hours (2-hour window will allow for implant insertion by 24 hours postpartum)
  • Aged 13 and older
  • English or Spanish speakers
  • Deliver an infant at UNM Hospital at > 37 weeks gestational age
  • Intend to breastfeed
  • Desire the implant as a method for contraception
  • Agree to randomization
  • Must have a working phone (study questions to be answered through phone calls or accessed electronically by a link sent through email or text message)

Exclusion Criteria:

  • Under age 13
  • History of breast cancer (screen by past medical history)
  • History of undiagnosed vaginal bleeding (screen by past medical history)
  • Head trauma that affected pituitary function (screen by past medical history)
  • Prolactin insufficiency (screen by past medical history)
  • Previous lactation failure (defined as no lactation within 5 days postpartum)
  • Any contraindication to lactation/implant use including diseases transmittable by breast milk (screen by past medical history)
  • Liver dysfunction (screen by past medical history)
  • Use of drugs that inhibit lactation (screen by medical history)
  • Sensitivity to the components of the ENG implant (screen by past medical history)
  • Contraindications to use the implant by the (US MEC) (screen by past medical history)
  • Active labor
  • Delivery at < 37 weeks gestational age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate insertion group
Immediate insertion in the first 24 hours after delivery ENG implant insertion Intervention.
Drug: Etonogestrel
Immediate v. Standard insertion.
Device: Nexplanon
Implant.
Active Comparator: Standard Postpartum Insertion Group
Insertion of the Etonogestrel implant 4-6 weeks postpartum Intervention.
Drug: Etonogestrel
Immediate v. Standard insertion.
Device: Nexplanon
Implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuation of breastfeeding.
Time Frame: For the primary outcome will be the first eight weeks after delivery.
Using a questionnaire the investigators seek to compare continuation of lactation between women in the immediate versus standard group. This will be assessed by answering a question with a dichotomous scale of yes or no in the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
For the primary outcome will be the first eight weeks after delivery.
Time to lactogenesis.
Time Frame: First 7 days.
To compare time to lactogenesis stage II between women in the immediate versus standard group.
First 7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exclusive breastfeeding.
Time Frame: Up to 24 weeks postpartum.

Using a questionnaire the investigators seek to compare exclusive breastfeeding through 6 months postpartum between the immediate versus the standard group. This will be assessed by answering a trichotomous question with the following statement:

If you are currently breastfeeding, are you:

  • Exclusively breastfeeding
  • Breastfeeding and supplementing breastfeeding with bottles of breast milk
  • Breastfeeding and supplementing breastfeeding with bottles of formula This question is part of the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum.
Up to 24 weeks postpartum.
Factors associated with breastfeeding discontinuation.
Time Frame: Up to 24 weeks postpartum.

Using a questionnaire the investigators seek to compare factors associated with discontinuing breastfeeding between the immediate versus the standard group. To asses this outcome a four-point Likert scale will be used with the following anchors: not at all important, not very important, somewhat important and very important.

This question is part of the follow-up questionnaire administer at 2,4,8,12 and 24 weeks postpartum
Up to 24 weeks postpartum.
Satisfaction with postpartum contraception counseling
Time Frame: Up to 24 weeks postpartum.
Using a questionnaire the investigators seek to compare participant satisfaction with postpartum contraception counseling. This will be assessed by a questionnaire of six questions using a Likert rating scale including poor, fair, good, very good and excellent. T
Up to 24 weeks postpartum.
Postpartum mood.
Time Frame: Up to 24 weeks postpartum.
To compare postpartum mood as measured by Edinburgh Postnatal Depression Scale (EPDS) score at 2, 4, 8, 12 and 24 weeks postpartum. Results reported as a total score ranging from 0-30, no subscale scores. A higher scale represents a worse outcome, ie. is more predictive of a depressive disorder including postpartum depression.
Up to 24 weeks postpartum.
Sexual Function.
Time Frame: Up to 24 weeks postpartum.

To compare postpartum sexual function as measured by Female Sexual Function Index (FSFI) score. Minimum score 2, Maximum score 36. Subscales are combined by first totaling the scores for the individual questions in that domain (ex. for Desire, the sum of scores for questions 1 and 2). That total is then multiplied by the factor for that domain, which is listed in the table above. The output is the final score for that domain, and will fall within the minimum and maximum scores listed in the table above.

For every domain, a lower score indicates either no sexual activity or negative outcomes in that domain, while a higher score indicates positive outcomes in that domain.
Up to 24 weeks postpartum.
Postpartum bleeding days.
Time Frame: Up to 24 weeks postpartum.
To compare the total number of days of postpartum bleeding in the immediate versus standard group during the study period.
Up to 24 weeks postpartum.
Satisfaction with timing of implant insertion: questionnaire
Time Frame: Up to 24 weeks postpartum.
Using a questionnaire the investigators seek to compare participant satisfaction with the timing of ENG implant insertion between the immediate versus the standard group. This will be assessed by a questionnaire using a four-point Likert scale including very unsatisfied, unsatisfied, satisfied and very satisfied.
Up to 24 weeks postpartum.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Jamie Krashin@salud.unm.edu, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2019

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 7, 2019

Study Record Updates

Last Update Posted (Actual)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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