Conditions: Infant, Premature Premature Birth
Keywords: Pre Term Pre Term Birth Premature Birth Premature baby High risk pregnancy Progesterone IM Progesterone Vaginal Progesterone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 174
Healthy volunteers: yes

Brief summary:
This is a randomized controlled trial comparing weekly intramuscular injection of 17 alpha hydroxylprogesterone caproate with daily vaginal progesterone in women with singleton pregnancies and history of prior spontaneous preterm birth in terms of maternal, fetal and neonatal outcomes.

Our aim is to assess the effects on maternal, fetal and neonatal outcomes of antenatal progesterone administered intramuscularly versus vaginally in women with singleton pregnancy and a history of prior preterm birth.

Detailed description:
This study is intended as a randomized controlled trial. Women with singleton pregnancies between 16 and 20 weeks 6 day will be randomized to one of two treatment groups.

Those randomized to weekly intramuscular progesterone will receive 250 mg of 17 alpha hydroxyprogesterone caproate every week in the clinic between randomization and delivery for those delivery preterm or 36 weeks 6 days.

While those randomized to vaginal progesterone will receive 100 mg vaginal progesterone daily at home. Vaginal progesterone to last between clinic visits will be provided to subject. Those women in the vaginal progesterone group will also be informed on how to obtain additional medication in case of missed clinic appointment. Treatment will be continued until 36 weeks 6 days or as dictated by date of preterm delivery.

Arms:
arm 1: Intramuscular Progesterone arm 2: Vaginal Progesterone

Interventions: intervention 1: Intramuscular Progesterone intervention 2: Vaginal Progesterone
Intervention descriptions: intervention 1: Intramuscular Progestone: 17 alpha hydroxyprogesterone caproate: weekly 1 cc injections containing 250 mg of 17P intervention 2: Vaginal Progesterone: 100 mg vaginal suppository daily

Protocol document: