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临床试验/NCT02416687
NCT02416687已完成4 期

Immediate Post-partum Initiation of Etonogestrel-releasing Implant: a Randomized Controlled Trial on Breastfeeding Impact

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
24
试验地点
2
主要终点
breast milk intake

研究概览

简要总结

The etonogestrel (ENG) implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.

详细描述

What is known already: The ENG implant inserted immediately postpartum reduces the risk of pregnancy recurrence, especially in vulnerable populations. A limitation to recommending this practice universally is the low quality of evidence on the effect of the ENG implant on breastfeeding when inserted immediately postpartum. This study is the first assessing the impact of inserting the ENG implant immediately postpartum on the amount of milk using the gold standard method for this purpose.

Study design, size, duration: This randomized, single-blind and controlled clinical trial evaluated 24 postpartum women and their NBs and was conducted at the Women's Health Reference Center of Ribeirão Preto, Brazil. The mother-NB pairs were evaluated for six weeks postpartum.

Participants/materials, setting, methods: Twenty-four mother-NB pairs were randomized into two groups: a) Implant group: ENG-releasing implant inserted within 48 h after delivery and b) Control group: absence of contraceptive method for six weeks after delivery. Anthropometric assessments and breastfeeding questionnaires were conducted at 4-time points of the 6-week monitoring period (at study admission and on the 14th, 29th and 43rd days after randomization). Saliva samples were collected from the mother-NB pairs prior to deuterium (D2O) dose administration. Totals of 5 g and 10 g D2O were orally administered to the postpartum women on the day of randomization (day 0) and the 29th study day, respectively. New saliva samples were collected on days 1, 2, 3, 4, 13 and 14 following intake of each D2O dose. The D2O isotope ratio was assessed in saliva samples using mass spectrometry to estimate the volume of breast milk ingested by the NB (daily average expressed as mL/day).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Postpartum women aged 18 years or older who agreed to use the ENG implant as a contraceptive method,
  • Body mass index (BMI) <30 kg/m2,
  • Women without contraindication to breastfeeding,
  • Women whose newborns were healthy, without malformations, born at term (gestational age ≥ 37 weeks), with appropriate weight for gestational age and with normal sucking ability, were included.
  • The subjects had to live in Ribeirão Preto and to have breastfed a child from a previous delivery for at least 3 months.

排除标准

  • Tobacco smokers, drug addicts or alcoholics,
  • Women with educational levels lower than 5 years,
  • Women with clinical conditions considered category 3 and 4 for implant use (except insertion immediately postpartum) by the WHO (World Health Organization, 2009),
  • Women with histories of psychiatric illness,
  • Women using medications that could alter the concentration of etonogestrel,
  • Women with known allergies to the local anesthetic lidocaine (used to place the implant),
  • Women who wanted to keep their cyclic menstrual bleeding

结局指标

主要结局

breast milk intake

时间窗: Six weeks after delivery

The primary outcome was the amount of breast milk intake by the NBs through breastfeeding in the first six weeks after delivery

次要结局

  • Exclusive breastfeeding(Six weeks after delivery)
  • Newborn weight(Six weeks after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolina Sales Vieira

Professor, MD

University of Sao Paulo

研究点 (2)

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