Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely (NCT02545127) | Clinical Trial Compass
TerminatedPhase 2
Merotocin in Mothers With Inadequate Milk Production and Infants Delivered Prematurely
Stopped: The trial was prematurely terminated. Termination was not because of safety concerns but due to slow recruitment.
United States4 participantsStarted 2021-05-28
Plain-language summary
Induction and support of lactation in women with preterm delivery and inadequate milk production.
Who can participate
Age range
18 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Delivered at the hospital system associated with the trial center
* Delivered preterm singleton gestational age 24 weeks + 0 days to 34 weeks + 2 days
* Willing to express milk at least 5 times every 24 hours during the observation period and 6 to 8 times every 24 hours during the treatment and post-treatment follow up
* Produced \< 200 mL milk in 24 hours prior to randomization
* Delivered 96 to 192 (+4) hours prior to randomization
Exclusion Criteria:
* Pre-pregnancy body mass index (BMI) \> 50 kg/m\^2
* Mastitis
* History of breast trauma, breast surgery, nipple piercing
* Prolactin-releasing pituitary tumor, history of Sheehan's syndrome, pituitary surgery/radiation therapy
* Pre-pregnancy insulin-dependent diabetes mellitus, polycystic ovarian syndrome. Note: gestational diabetes is allowed (also when requiring the use of insulin for treatment)
* Unstable thyroid disease
* Moderate or severe renal or hepatic impairment
* Mental illness
* Significant nasal congestion or mucous production
* Use of anti-psychotic drugs within past 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.