Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.

Study Overview

• Status: Completed
• Conditions: Complications; Contraceptive; Female Lactation
• Intervention / Treatment: Drug: Etonogestrel contraceptive implant; Drug: Etonogestrel contraceptive implant

Detailed Description

This is a randomized controlled trial. Participants will be assigned with equal probability to 1 of the 2 test groups using computer-generated random numbers in blocks of varying sizes. Allocation concealment will be assured by enclosing assignments in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and study number are written on the envelope. Follow-up and data collection for participants in each group will be identical. Outcome assessors and data analysts will be blinded to treatment arm.

STUDY PROCEDURES:

Inclusion/exclusion criteria will be verified and consent obtained. The patient will be notified of the results of randomization and the physician able to perform insertion will be contacted to perform the insertion. All insertions will be performed by physicians who have completed Implanon® insertion training. If the patient randomizes to standard postpartum insertion, she will be given a clinic appointment in 4-8 weeks for the insertion procedure.

Lactogenesis time will be documented by maternal perception, as described and validated by Chapman et al16. If lactogenesis has not occurred prior to hospital discharge, the patient will receive daily phone calls from study personnel until lactogenesis can be confirmed and recorded. Contact information for the patient, as well as for two friends or relatives who will know how to reach her will be obtained and verified prior to discharge. Participants will be given a reminder card for the telephone calls from the investigator and a postpartum visit appointment. Patients will be instructed to contact the investigators immediately for pain, excessive bleeding, difficulty with breastfeeding, or other concerns. Patients will be given a log book ("diary") to record breastfeeding parameters including use of supplementation, infant weights, side effects, return to sexual intercourse, contraceptive method use, and days of bleeding for the study follow-up period.

Clinical follow-up will be as follows. Postpartum telephone calls or visits to collect additional data will occur as needed for up to 5 days following hospital discharge, at 2 weeks, 4-8 weeks, and 3 and 6 months postpartum. Information obtained at these points will include: breastfeeding status and parameters, collection of record of infant weights (birth, 4-8 weeks, and 6 months), reminders to keep weekly diary, collection of diaries (6 month visit), resumption of sexual activity, use of contraceptive method, and satisfaction with contraceptive method. Patients randomized to early insertion will be asked to give a milk sample for analysis at their 4-8 week visit. Table 1 describes the contact points with the subject for collection of data. Contact will be either by telephone or at clinic visits.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84105
      • University of Utah Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: Patients on the postpartum ward at University Hospital will be offered inclusion in the study if they are:

• healthy,
• 18-40 years old,
• delivered a healthy term infant,
• intend to breastfeed,
• desire Implanon as their method of contraception, and
• agree to be randomized to early versus standard postpartum insertion.

Exclusion Criteria:

• obstetric complications including anemia with hematocrit<30,
• transfusion,
• infection,
• severe pregnancy induced hypertension,
• prolonged hospitalization,
• coagulopathy,
• liver disease,
• undiagnosed genital bleeding,
• or other relative contraindication to Implanon® insertion (known or suspected pregnancy, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in Implanon®).
• Women taking drugs that are potent inducers of hepatic enzymes will also be excluded, including barbiturates, griseofulvin, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, modafinil, protease inhibitors, and herbal products including St. John's Wort.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Early postpartum insertion	Drug: Etonogestrel contraceptive implant; Implant insertion postpartum prior to hospital discharge; Drug: Etonogestrel contraceptive implant; Standard insertion at 4-8 weeks postpartum
Active Comparator: 2; Standard postpartum insertion	Drug: Etonogestrel contraceptive implant; Implant insertion postpartum prior to hospital discharge; Drug: Etonogestrel contraceptive implant; Standard insertion at 4-8 weeks postpartum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Lactogenesis Stage II	The primary outcome, time to lactogenesis stage II in hours, was documented by maternal perception as previously described and validated in the literature. Subjects were asked, "Has your milk come in? Some women experience this as a prickly feeling or tingling in the breast, dripping from the other nipple when nursing, milk running from the baby's mouth, or gulping by the baby. " If the response was positive, subjects were then asked, "When did your milk come in?" and the response recorded to the nearest hour.	5 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crematocrit of Human Milk	Determination of creamatocrit is a simple method for estimating the fat & energy content of human milk based on the centrifugation of milk in a hematocrit centrifuge. The method for creamatocrit measurement was as described by Lucas et al (LucasA, GibbsJA, LysterRL, BaumJD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. BritMedJnl1978;1:1018-20)using a standard hematocrit centrifuge, standard hematocrit glass capillary tube, & vernier calipers. Measurements were performed in duplicate and the mean for each measurement used for analysis.	6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Shawn E Gurtcheff, MD, University of Utah; Study Chair: David K Turok, MD, University of Utah; Study Director: Kirtly P Jones, MD, University of Utah; Study Director: Patricia Murphy, DrPH, University of Utah; Study Director: Sara E Simonsen, RN, BSN, University of Utah

Publications and helpful links

General Publications

• Gurtcheff SE, Turok DK, Stoddard G, Murphy PA, Gibson M, Jones KP. Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial. Obstet Gynecol. 2011 May;117(5):1114-1121. doi: 10.1097/AOG.0b013e3182165ee8.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): April 18, 2016
• Last Update Submitted That Met QC Criteria: March 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Breastfeeding; Implant; Contraceptive; Postpartum period; etonogestrel-releasing; lactogenesis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Progestins; Contraceptive Agents; Desogestrel; Etonogestrel
• Other Study ID Numbers: 30291 (Other Identifier: Temple Institutional Review Board)