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

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ClinicalTrials.gov Identifier: NCT01388582

Recruitment Status : Completed

First Posted : July 6, 2011

Last Update Posted : May 17, 2012

Sponsor:

Collaborator:

Fundação de Amparo à Pesquisa do Estado de São Paulo

Information provided by (Responsible Party):

Luis Bahamondes, University of Campinas, Brazil

Study Description

Brief 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.

Condition or disease	Intervention/treatment	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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	April 2011
Actual Primary Completion Date :	August 2011
Actual Study Completion Date :	August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Drug Information available for: Etonogestrel

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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 ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01388582

Locations

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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

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Principal Investigator:	Luis Bahamondes, MD	University of Campinas

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bahamondes L, Bahamondes MV, Modesto W, Tilley IB, Magalhães A, Pinto e Silva JL, Amaral E, Mishell DR Jr. Effect of hormonal contraceptives during breastfeeding on infant's milk ingestion and growth. Fertil Steril. 2013 Aug;100(2):445-50. doi: 10.1016/j.fertnstert.2013.03.039. Epub 2013 Apr 23.

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Responsible Party:	Luis Bahamondes, MD Medical Doctor, University of Campinas, Brazil
ClinicalTrials.gov Identifier:	NCT01388582
Other Study ID Numbers:	06/2011/PC
First Posted:	July 6, 2011 Key Record Dates
Last Update Posted:	May 17, 2012
Last Verified:	May 2012

Keywords provided by Luis Bahamondes, University of Campinas, Brazil:


contraceptives hormonal breastfeeding infant weight

Additional relevant MeSH terms:

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Thinness Body Weight Copper Contraceptive Agents Levonorgestrel Etonogestrel Desogestrel Contraceptives, Oral Reproductive Control Agents Physiological Effects of Drugs	Contraceptive Agents, Female Trace Elements Micronutrients Contraceptive Agents, Hormonal Contraceptives, Oral, Synthetic Contraceptives, Oral, Hormonal Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists

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