Etonogestrel Implant and Postpartum Insertion

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416687
• Other study ID #: 62798
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2015
• Last updated: April 22, 2015
• Start date: March 2014
• Est. completion date: January 2015

Study information

• Verified date: April 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Implanon®
Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum

Locations

Country	Name	City	State
Brazil	Hospital das Clinica de Ribeirao Preto	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Exclusive breastfeeding	Rate of exclusive breastfeeding	Six weeks after delivery	Yes
Secondary	Newborn weight	Weight gain by newborns in six weeks after delivery	Six weeks after delivery	Yes