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 range18 Years – 44 Years
SexFEMALE
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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