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

Purpose

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.

Condition	Intervention	Phase
Underweight	Device: LNG-IUS Device: Implanon Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar) Device: TCu380A copper-intrauterine device Device: TCu380A intrauterine device	Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Breast Feeding

Drug Information available for: Levonorgestrel Etonogestrel

U.S. FDA Resources

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.

Enrollment:	40
Study Start Date:	April 2011
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Combined oral contraceptive 10 women will receive COC during breastfeeding	Drug: 30 mcg EE and 150 LNG oral contraceptive (Microvlar) 10 women will receive oral contraceptive during breastfeeding Other Name: Microvlar (Bayer, Brazil) Device: TCu380A intrauterine device 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding Other Names: Implanon, MSD, Os, The Netherland Mirena, Bayer Oy, Tuku, Finland TCu380A copper intrauterine device; Optima, Injeflex, Brazil Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Active Comparator: Levonorgestrel intrauterine system 10 women will receive a LNG-IUS during breastfeeding	Device: LNG-IUS 10 women will receive the LNG-IUS during breastfeeding Other Name: Mirena, Bayer, Brazil Device: TCu380A intrauterine device 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding Other Names: Implanon, MSD, Os, The Netherland Mirena, Bayer Oy, Tuku, Finland TCu380A copper intrauterine device; Optima, Injeflex, Brazil Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Active Comparator: Implanon 10 women will receive Implanon during breastfeeding	Device: Implanon 60 mcg/day contraceptive implant Other Name: Implanon, MSD, Brazil Device: TCu380A intrauterine device 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding Other Names: Implanon, MSD, Os, The Netherland Mirena, Bayer Oy, Tuku, Finland TCu380A copper intrauterine device; Optima, Injeflex, Brazil Microvlar oral contraceptive, Bayer, São Paulo, Brazil
Active Comparator: TCu380A intrauterine device 10 women will receive a TCu380A intrauterine device as non hormonal 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 Other Name: Optima IUD (Injeflex, Brazil) Device: TCu380A intrauterine device 10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding Other Names: Implanon, MSD, Os, The Netherland Mirena, Bayer Oy, Tuku, Finland TCu380A copper intrauterine device; Optima, Injeflex, Brazil Microvlar oral contraceptive, Bayer, São Paulo, Brazil

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01388582

Locations

Brazil
University of Campinas
Campinas, SP, Brazil, 13083-888

Sponsors and Collaborators

University of Campinas, Brazil

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

Principal Investigator:

Luis Bahamondes, MD

University of Campinas

More Information

No publications provided

Responsible Party:	Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT01388582 History of Changes
Other Study ID Numbers:	06/2011/PC
Study First Received:	June 16, 2011
Last Updated:	May 16, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:

contraceptives
hormonal
breastfeeding
infant weight

Additional relevant MeSH terms:

Thinness
Body Weight
Signs and Symptoms
Contraceptive Agents
Levonorgestrel
3-keto-desogestrel
Contraceptives, Oral
Contraceptives, Oral, Combined
Copper

Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Trace Elements
Micronutrients
Growth Substances
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on June 17, 2013