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

Sponsor

University of Campinas, Brazil (Other)

Overall Status

Completed

CT.gov ID

NCT01388582

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

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: LNG-IUS 10 women will receive the LNG-IUS during breastfeeding Other Names: 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 Names: 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 Names: 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

Outcome Measures

Primary Outcome Measures

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.