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Completed

NCT Number: NCT01388582

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Campinas

Campinas, São Paulo, 13083-888, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

LNG-IUS

Device

10 women will receive the LNG-IUS during breastfeeding

Other names: Mirena, Bayer, Brazil

Implanon

Device

60 mcg/day contraceptive implant

Other names: Implanon, MSD, Brazil

30 mcg EE and 150 LNG oral contraceptive (Microvlar)

Drug

10 women will receive oral contraceptive during breastfeeding

Other names: Microvlar (Bayer, Brazil)

TCu380A copper-intrauterine device

Device

Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group

Other names: Optima IUD (Injeflex, Brazil)

TCu380A intrauterine device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 6, 2011
Registry last updated
May 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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