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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This study has been withdrawn prior to enrollment.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
  Purpose

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
Lactation

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Enrollment: 0
Actual Study Start Date: June 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
combined contraceptives
combined contraceptives
pregesterone only contraceptives
pregesterone only contraceptives

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00374972     History of Changes
Other Study ID Numbers: 40106
Study First Received: September 11, 2006
Last Updated: May 14, 2017

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

ClinicalTrials.gov processed this record on May 23, 2017