Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combined Hormonal Versus Progestin Only Contraception During Lactation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Organon
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00374972
First received: September 11, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

September 11, 2006
September 11, 2006
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Combined Hormonal Versus Progestin Only Contraception During Lactation
Not Provided

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

Not Provided
Observational
Allocation: Random Sample
Time Perspective: Longitudinal
Not Provided
Not Provided
Not Provided
Not Provided
Lactation
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
Not Provided
Not Provided

Inclusion Criteria:

  • healthy

Exclusion Criteria:

  • mothers to infants that their weight will be below the 10th percentile
  • mothers to infants sensitive to milk
Female
18 Years to 50 Years
Yes
Not Provided
 
NCT00374972
40106
Not Provided
Not Provided
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
August 2006

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