Randomized Trial of Maternal Progesterone Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

November 30, 2021

Study Completion Date

November 30, 2021

Conditions
Congenital Heart DiseasePeriventricular LeucomalaciaBrain DevelopmentCardiac SurgeryNeurodevelopmental DisabilityFetal Neuroprotection
Interventions
DRUG

Progesterone

Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.

DRUG

Vaginal lubricant

Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.

Trial Locations (1)

19104

The Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
lead

Children's Hospital of Philadelphia

OTHER

NCT02133573 - Randomized Trial of Maternal Progesterone Therapy | Biotech Hunter | Biotech Hunter