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

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Luis Bahamondes, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01388582
First received: June 16, 2011
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Underweight
Device: LNG-IUS
Device: Implanon
Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
Device: TCu380A copper-intrauterine device
Device: TCu380A intrauterine device
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: April 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: LNG-IUS
10 women will receive the LNG-IUS during breastfeeding
Other Name: Mirena, 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: Implanon
10 women will receive Implanon during breastfeeding
Device: Implanon
60 mcg/day contraceptive implant
Other Name: Implanon, MSD, 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: TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding
Device: TCu380A copper-intrauterine device
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
Other Name: Optima IUD (Injeflex, 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

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.

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  • baby premature
  • diabetes
  • blood hypertension
  • not breastfeeding or partial breastfeeding
  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: NCT01388582

Locations
Brazil
University of Campinas
Campinas, SP, Brazil, 13083-888
Sponsors and Collaborators
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Luis Bahamondes, MD University of Campinas
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01388582     History of Changes
Other Study ID Numbers: 06/2011/PC
Study First Received: June 16, 2011
Last Updated: May 16, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
contraceptives
hormonal
breastfeeding
infant weight

Additional relevant MeSH terms:
3-keto-desogestrel
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Copper
Levonorgestrel
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Trace Elements

ClinicalTrials.gov processed this record on October 20, 2014