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Combined Hormonal Versus Progestin Only Contraception During Lactation

This study has been withdrawn prior to enrollment.
(difficulty in recruitment. lack of sponsorship)
Sponsor:
Collaborator:
Organon
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00374972
First received: September 11, 2006
Last updated: May 14, 2017
Last verified: April 2017
September 11, 2006
May 14, 2017
June 2006
January 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00374972 on ClinicalTrials.gov Archive Site
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Combined Hormonal Versus Progestin Only Contraception During Lactation
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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

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Observational
Time Perspective: Prospective
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Lactation
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  • combined contraceptives
    combined contraceptives
  • pregesterone only contraceptives
    pregesterone only contraceptives
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
January 2007
January 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • mothers to infants that their weight will be below the 10th percentile
  • mothers to infants sensitive to milk
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00374972
40106
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Shaare Zedek Medical Center
Organon
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
Shaare Zedek Medical Center
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP