LactationNCT00374972
Combined Hormonal Versus Progestin Only Contraception During Lactation
An observational study of Lactation, run by Shaare Zedek Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
Who cannot join
- mothers to infants that their weight will be below the 10th percentile
- mothers to infants sensitive to milk
About this study
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.
Read more
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
- Conditions
- Lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| combined contraceptives | combined contraceptives | |
| pregesterone only contraceptives | pregesterone only contraceptives |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: difficulty in recruitment. lack of sponsorship
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Investigators
- Naama Srebnik, MD, Principal investigator, A resident at the Shaare Zedek Medical CenterSurina Grisaru-Granovsky, Study director, A senior doctor at the Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374972
- Sponsor's protocol ID
- 40106
- Status last verified
- Apr 2017
- First submitted
- 11 Sep 2006
- Last updated
- 16 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Hormonal Versus Progestin Only Contraception During Lactation
- ClinicalTrials.gov ID
- NCT00374972
- Acronym / sponsor ID
- 40106
- Conditions
- Lactation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: difficulty in recruitment. lack of sponsorship
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Jun 2006 (actual)
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined contraceptives | – | –combined contraceptives |
| pregesterone only contraceptives | – | –pregesterone only contraceptives |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (2 listed)
- mothers to infants that their weight will be below the 10th percentile
- mothers to infants sensitive to milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naama Srebnik, MD principal investigator
A resident at the Shaare Zedek Medical Center
Surina Grisaru-Granovsky study director
A senior doctor at the Shaare Zedek Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Lactation, run by Shaare Zedek Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.