Etonogestrel Implant and Postpartum Insertion

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: Implanon®

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Ribeirão Preto, SP, Brazil, 14049-900
      • Hospital das Clinica de Ribeirao Preto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Implanon®; Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) was inserted in the first 48 h postpartum	Device: Implanon®; Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum; Other Names: etonogestrel-releasing implant (Implanon)
NO_INTERVENTION: Control group; Postpartum women who used no contraceptive method in the first six weeks after delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
breast milk intake	The primary outcome was the amount of breast milk intake by the NBs through breastfeeding in the first six weeks after delivery	Six weeks after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exclusive breastfeeding	Rate of exclusive breastfeeding	Six weeks after delivery
Newborn weight	Weight gain by newborns in six weeks after delivery	Six weeks after delivery

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (ESTIMATE): April 15, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): April 24, 2015
• Last Update Submitted That Met QC Criteria: April 22, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Etonogestrel
• Other Study ID Numbers: 62798