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Combined Hormonal Versus Progestin Only Contraception During Lactation

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ClinicalTrials.gov Identifier: NCT00374972
Recruitment Status : Withdrawn (difficulty in recruitment. lack of sponsorship)
First Posted : September 12, 2006
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
Organon
Information provided by:
Shaare Zedek Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Objective: To determine and compare the effect of low dose estrogen combined hormonal contraceptives and progestin-only contraceptives on lactation.

The subjects will be drawn from a healthy obstetric population in each center, where possible preliminary contact during antenatal period. At the postpartum visit, subjects that express their wish for a hormonal contraceptive method will be offered enrollment. After obtaining an informed consent the participants will be allocated according to their free wish to either receive a combined preparation containing 0.02 mg ethylestradiol and 0.15 mg desogestrel (Mercilon, Organon) or a progestin only pill containing 0.075 mg desogestrel (Cerazette, Organon). Demographic, habits and perinatal data will be collected and stored to analysis.

Frequency and methods of observation: All women will be followed at 6 (baseline), 9 and 12 weeks post - partum. Instruction will be given as to recording information on intercurrent disease, frequency of nursing and use of complementary formula supplements. Maternal BMI calculation ( weight/height2) will be obtained at first visit.

The objective is to compare the capacity of the breast to secrete milk under standard conditions and evaluate the influence of different hormonal contraception means. Thus samples will be collected at 6 weeks (enrollment) and the 9 and 12 weeks visits. An Egnell pump will be used for a maximum of 20 minutes form from both breasts, simulating a regular breast feeding. A total of 10 ml aliquot will be taken for composition analysis and the rest will be offered to the infant. The milk volume/feeding will be estimated and expressed in ml/feeding and multiplied by the number of feedings reported.

Outcome variables: Milk volume, infant growth at each visit and biochemical markers of milk analysis : lipid, casein and carbohydrate content


Condition or disease
Lactation

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Time Perspective: Prospective
Actual Study Start Date : June 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

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U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
combined contraceptives
combined contraceptives
pregesterone only contraceptives
pregesterone only contraceptives


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • mothers to infants that their weight will be below the 10th percentile
  • mothers to infants sensitive to milk
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00374972


Sponsors and Collaborators
Shaare Zedek Medical Center
Organon
Investigators
Principal Investigator: Naama Srebnik, MD A resident at the Shaare Zedek Medical Center
Study Director: Surina Grisaru-Granovsky A senior doctor at the Shaare Zedek Medical Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00374972     History of Changes
Other Study ID Numbers: 40106
First Posted: September 12, 2006    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs