Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00847587
First received: February 18, 2009
Last updated: June 10, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Complications; Contraceptive
Female Lactation
Drug: Etonogestrel contraceptive implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Time to Lactogenesis Stage II [ Time Frame: 5 days postpartum ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Crematocrit of Human Milk [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Early postpartum insertion
Drug: Etonogestrel contraceptive implant
Implant insertion postpartum prior to hospital discharge
Active Comparator: 2
Standard postpartum insertion
Drug: Etonogestrel contraceptive implant
Standard insertion at 4-8 weeks postpartum

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847587

Locations
United States, Utah
University of Utah Hospital
Salt Lake City, Utah, United States, 84105
Sponsors and Collaborators
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
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shawn E. Gurtcheff, MD Visiting Instructor, University of Utah Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00847587     History of Changes
Other Study ID Numbers: 30291
Study First Received: February 18, 2009
Results First Received: March 10, 2011
Last Updated: June 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Contraceptive
Implant
Postpartum period
etonogestrel-releasing
lactogenesis
Breastfeeding

Additional relevant MeSH terms:
3-keto-desogestrel
Contraceptive Agents
Desogestrel
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014