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

Underweight Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01388582
• Other study ID #: 06/2011/PC
• Status: Completed
• Phase: Phase 4
• First received: June 16, 2011
• Last updated: May 16, 2012
• Start date: April 2011
• Est. completion date: August 2011

Study information

• Verified date: May 2012
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS. All women will be offered nonhormonal contraceptives prior to randomization. The pairs will then be followed for four weeks. During this follow-up period, breast-milk intake will be quantified by administering deuterium oxide to exclusively breast-feeding mothers and measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric measurements will be collected -- both as a value necessary to implement the breast-milk quantification method, as well as an outcome for analysis, and a daily diary will be kept by the women participating in the study that records infant feeds and diaper changes.

Description:

Women where allocated to an oral combined contraceptive pill, or placebo or a LNG-IUS or a etonogestrel-releasing subdermal contraceptive implant at day 42 after delivery. After the provision of the contraceptive method a 0.5 mg/kg of deuterium 99.99% according to the weight of the mother will be administer to all women. One sample of saliva from the mother and the child will be collected every day until 21 days after enrollment. Additionally, weight, height and size of the leg of each child will be measured at baseline, at the day 11 and at the day 21 after enrollment. Also, a diary with information of change of diapers and number of breastfeeding will be kept by each mother.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• baby premature

• diabetes

• blood hypertension

• not breastfeeding or partial breastfeeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Underweight

Intervention

Device:
• LNG-IUS
10 women will receive the LNG-IUS during breastfeeding
• Implanon
60 mcg/day contraceptive implant

Drug:
• 30 mcg EE and 150 LNG oral contraceptive (Microvlar)
10 women will receive oral contraceptive during breastfeeding

Device:
• TCu380A copper-intrauterine device
Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
• TCu380A intrauterine device
10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding

Locations

Country	Name	City	State
Brazil	University of Campinas	Campinas	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of infant weight, height and size of the tibial	The study have the purpose to evaluate the infant weight, height and size of the tibial in infant who breastfeeding on demand exclusively and their mother were either users of a combined oral contraceptive, placebo, etonogestrel-releasing subdermal contraceptive implant or levonorgestrel-releasing intrauterine system. Additionally, pregnancy effectiveness and any adversse event will record in all groups of women.	women and children will be evaluated at time frame from day 42 through day 64 post-partum	Yes