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

June 16, 2011
May 16, 2012
April 2011
August 2011   (final data collection date for primary outcome measure)
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.
Evaluation of infant growth [ 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 growth through the height, weight and tibial measurement 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.
Complete list of historical versions of study NCT01388582 on ClinicalTrials.gov Archive Site
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The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Underweight
  • Device: LNG-IUS
    10 women will receive the LNG-IUS during breastfeeding
    Other Name: Mirena, Bayer, Brazil
  • Device: Implanon
    60 mcg/day contraceptive implant
    Other Name: Implanon, MSD, Brazil
  • 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 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
  • Active Comparator: Combined oral contraceptive
    10 women will receive COC during breastfeeding
    Interventions:
    • Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
    • Device: TCu380A intrauterine device
  • Active Comparator: Levonorgestrel intrauterine system
    10 women will receive a LNG-IUS during breastfeeding
    Interventions:
    • Device: LNG-IUS
    • Device: TCu380A intrauterine device
  • Active Comparator: Implanon
    10 women will receive Implanon during breastfeeding
    Interventions:
    • Device: Implanon
    • Device: TCu380A intrauterine device
  • Active Comparator: TCu380A intrauterine device
    10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding
    Interventions:
    • Device: TCu380A copper-intrauterine device
    • Device: TCu380A intrauterine device
Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhães A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Aug;100(2):445-50. doi: 10.1016/j.fertnstert.2013.03.039. Epub 2013 Apr 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • baby premature
  • diabetes
  • blood hypertension
  • not breastfeeding or partial breastfeeding
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01388582
06/2011/PC
No
Luis Bahamondes, University of Campinas, Brazil
University of Campinas, Brazil
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Luis Bahamondes, MD University of Campinas
University of Campinas, Brazil
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP