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临床试验/NCT01388582
NCT01388582已完成4 期

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

University of Campinas, Brazil1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Evaluation of infant weight, height and size of the tibial

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Combined oral contraceptive

Active Comparator

10 women will receive COC during breastfeeding

干预措施: 30 mcg EE and 150 LNG oral contraceptive (Microvlar) (Drug)

Combined oral contraceptive

Active Comparator

10 women will receive COC during breastfeeding

干预措施: TCu380A intrauterine device (Device)

Levonorgestrel intrauterine system

Active Comparator

10 women will receive a LNG-IUS during breastfeeding

干预措施: LNG-IUS (Device)

Levonorgestrel intrauterine system

Active Comparator

10 women will receive a LNG-IUS during breastfeeding

干预措施: TCu380A intrauterine device (Device)

Implanon

Active Comparator

10 women will receive Implanon during breastfeeding

干预措施: Implanon (Device)

Implanon

Active Comparator

10 women will receive Implanon during breastfeeding

干预措施: TCu380A intrauterine device (Device)

TCu380A intrauterine device

Active Comparator

10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding

干预措施: TCu380A copper-intrauterine device (Device)

TCu380A intrauterine device

Active Comparator

10 women will receive a TCu380A intrauterine device as non hormonal contraceptive during breastfeeding

干预措施: TCu380A intrauterine device (Device)

结局指标

主要结局

Evaluation of infant weight, height and size of the tibial

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Bahamondes

MD Medical Doctor

University of Campinas, Brazil

研究点 (1)

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