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

Phase 4

Completed

• Conditions: Underweight
• Interventions: Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar); Device: LNG-IUS; Device: Implanon; Device: TCu380A copper-intrauterine device; Device: TCu380A intrauterine device

• Registration Number: NCT01388582
• Lead Sponsor: University of Campinas, Brazil

Brief Summary

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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-07-05
• Study First Posted: 2011-07-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined oral contraceptive	30 mcg EE and 150 LNG oral contraceptive (Microvlar)	10 women will receive COC during breastfeeding
Combined oral contraceptive	TCu380A intrauterine device	10 women will receive COC during breastfeeding
Levonorgestrel intrauterine system	LNG-IUS	10 women will receive a LNG-IUS during breastfeeding
Levonorgestrel intrauterine system	TCu380A intrauterine device	10 women will receive a LNG-IUS during breastfeeding
Implanon	Implanon	10 women will receive Implanon during breastfeeding
Implanon	TCu380A intrauterine device	10 women will receive Implanon during breastfeeding
TCu380A intrauterine device	TCu380A copper-intrauterine device	10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding
TCu380A intrauterine device	TCu380A intrauterine device	10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding

Primary Outcome Measures

Name	Time	Method
Evaluation of infant weight, height and size of the tibial	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.

Trial Locations

Locations (1)

University of Campinas; 🇧🇷 Campinas, SP, Brazil