Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT03851718
Eligibility Criteria:
Inclusion Criteria:
1. Primipara or Multipara woman who had normal pregnancy (gestation ≥ 37 weeks gestation) and gave birth vaginally or by Caesarean section to a single child without complications and who are 2 weeks to 6 months postpartum.
2. Estimated milk production of \< 450 g/24 hours (or 450ml/24hours)-by self-report
3. A current body mass index (BMI) equal or above 18 kg/m2 and below 35 kg/ m2
4. Non-smoker. Subjects who have stopped smoking for \>6 months prior to study start may be included.
5. Must be fluent in English conversation, reading and writing.
Exclusion Criteria:
1. Presence or a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal systems or presence or history of clinically significant psychiatric, immunological, endocrine or metabolic diseases including gestational or pregestational diabetes, and Polycystic Ovarian syndrome.
2. History of breast cancer, breast surgery, or clinically significant abnormalities of the breasts that may affect the milk production and/or flow.
3. Use of typical and atypical antipsychotics, drugs/supplements, and/or other approaches that may increase milk production or prolactin levels in patients.
4. Consumes alcohol during breastfeeding.
5. Current case of infectious mastitis and/or Reynaud's disease of the breast.
6. History within the last two years or current abuse of alcohol or drugs.
7. Current non-smokers with a history of long-term, heavy smoking (\>10 pack-years).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03851718
Study Brief:
Protocol Section:
NCT03851718