The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01388582
• Date of registration: 16/06/2011
• Prospective Registration: No
• Primary sponsor: University of Campinas, Brazil
• Public title: The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
• Scientific title: 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
• Date of first enrolment: April 2011
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01388582
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
• Phase: Phase 4

Countries of recruitment

Brazil

Contacts

• Name: Luis Bahamondes, MD
• Affiliation: University of Campinas

Key inclusion & exclusion criteria

Inclusion Criteria:

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

Exclusion Criteria:

- baby premature

- diabetes

- blood hypertension

- not breastfeeding or partial breastfeeding



Age minimum: 18 Years
Age maximum: 40 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Underweight

Intervention(s)

Device: Implanon

Device: LNG-IUS

Device: TCu380A copper-intrauterine device

Device: TCu380A intrauterine device

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

Primary Outcome(s)

Evaluation of infant weight, height and size of the tibial [Time Frame: women and children will be evaluated at time frame from day 42 through day 64 post-partum]

Secondary ID(s)

06/2011/PC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fundação de Amparo à Pesquisa do Estado de São Paulo