The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth

May 16, 2012 updated by: Luis Bahamondes, University of Campinas, Brazil

The Effect of 30mcg and Levonorgestrel 150 Combined Oral Contraceptive, Etonogestrel-releasing Subdermal Implant and Levonorgestrel-releasing Intrauterine System on Breast-Milk Production and Infant Growth in Fully Breast-Feeding Women

The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. One sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. Additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. Also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • Brazil
    • SP
      • Campinas, SP, Brazil, 13083-888
        • University of Campinas

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women at the day 42th of post-partum fully breastfeeding-

Exclusion Criteria:

  • baby premature
  • diabetes
  • blood hypertension
  • not breastfeeding or partial breastfeeding

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combined oral contraceptive
10 women will receive COC during breastfeeding
Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
10 women will receive oral contraceptive during breastfeeding
Other Names:
  • Microvlar (Bayer, Brazil)
Device: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Other Names:
  • Implanon, MSD, Os, The Netherland
  • Mirena, Bayer Oy, Tuku, Finland
  • TCu380A copper intrauterine device; Optima, Injeflex, Brazil
  • Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Active Comparator: Levonorgestrel intrauterine system
10 women will receive a LNG-IUS during breastfeeding
Device: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Other Names:
  • Implanon, MSD, Os, The Netherland
  • Mirena, Bayer Oy, Tuku, Finland
  • TCu380A copper intrauterine device; Optima, Injeflex, Brazil
  • Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Device: LNG-IUS
10 women will receive the LNG-IUS during breastfeeding
Other Names:
  • Mirena, Bayer, Brazil
Active Comparator: Implanon
10 women will receive Implanon during breastfeeding
Device: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Other Names:
  • Implanon, MSD, Os, The Netherland
  • Mirena, Bayer Oy, Tuku, Finland
  • TCu380A copper intrauterine device; Optima, Injeflex, Brazil
  • Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Device: Implanon
60 mcg/day contraceptive implant
Other Names:
  • Implanon, MSD, Brazil
Active Comparator: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding
Device: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
Other Names:
  • Implanon, MSD, Os, The Netherland
  • Mirena, Bayer Oy, Tuku, Finland
  • TCu380A copper intrauterine device; Optima, Injeflex, Brazil
  • Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Device: TCu380A copper-intrauterine device
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
Other Names:
  • Optima IUD (Injeflex, Brazil)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of infant weight, height and size of the tibial
Time Frame: women and children will be evaluated at time frame from day 42 through day 64 post-partum
The study have the purpose to evaluate the infant weight, height and size of the tibial in infant who breastfeeding on demand exclusively and their mother were either users of a combined oral contraceptive, placebo, etonogestrel-releasing subdermal contraceptive implant or levonorgestrel-releasing intrauterine system. Additionally, pregnancy effectiveness and any adversse event will record in all groups of women.
women and children will be evaluated at time frame from day 42 through day 64 post-partum

Collaborators and Investigators

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

Sponsor

University of Campinas, Brazil

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Luis Bahamondes, MD, University of Campinas

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

April 1, 2011

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

July 5, 2011

First Posted (Estimate)

July 6, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2012

Last Update Submitted That Met QC Criteria

May 16, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06/2011/PC

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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