Etonogestrel Implant and Postpartum Insertion

NCT02416687 | Completed Phase 4

• 1 other identifier: 62798
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exclusive breastfeeding

  Six weeks after delivery

• Newborn weight

  Six weeks after delivery

Study Arms (2)

Implanon®

ACTIVE COMPARATOR

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®

Control group

NO INTERVENTION

Postpartum women who used no contraceptive method in the first six weeks after delivery

Interventions

Implanon® DEVICE

Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum

Also known as: etonogestrel-releasing implant (Implanon)

Implanon®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinica de Ribeirao Preto

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Study Officials

• Carolina S Vieira, MD, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

BR (1)