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Progesterone (17OHP) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM)

2014-07-23 21:09:16 | BioPortfolio

Summary

The objective of the study is to determine if a weekly dose of 17P given to women with preterm rupture of the membranes will:

1. increase the probability of continuing the pregnancy until a favorable gestational age.

2. increase the interval between randomization and delivery.

3. decrease neonatal morbidity.

Description

Preterm rupture of the membranes (PROM) is the leading identifiable cause of prematurity and accounts for about one-third of all preterm deliveries and 18-20% of perinatal deaths in the USA. When PROM occurs at very early gestational ages, the clinician must make a decision whether to attempt to prolong the pregnancy or whether to recommend prompt delivery. Both approaches carry substantial risk. The strategy of continuing the pregnancy is commonly called "expectant management." During expectant management, gestational age steadily increases, and the balance naturally shifts toward favoring delivery. Once the gestational age reaches 34 weeks, the risk of lethal or permanent sequelae of prematurity or minimal, so most clinicians agree that delivery is warranted. Despite an attempt at expectant management, the majority of patients with PROM will be delivered within the first week or so. Unfortunately, no intervention other than antibiotic prophylaxis or corticosteroids have been shown to prolong latency or reduce neonatal morbidity after PROM. Recent evidence suggests that prophylactic administration of progesterone medications may reduce the risk of preterm delivery in women with certain risk factors, notably those with a history of a prior preterm delivery and those with a shortened cervix discovered by ultrasound examination. Clearly, women with PROM are at very high risk of preterm delivery, so there is a pressing need to study whether 17P is effective after PROM. Progesterone might be beneficial after PROM both because it tends to promote uterine quiescence by suppressing the formation of myometrial gap junctions and because it has anti-inflammatory properties, suppressing the production of inflammatory cytokines and thereby inhibiting cervical ripening. Inflammation is a major pathway leading to preterm labor, cervical dilation & preterm delivery. 17P would seem to be like an ideal candidate for prolongation of pregnancy after PROM.

This is a double-blinded, placebo-controlled, multicenter, randomized clinical trial of 17P versus placebo. The primary outcome measure will be the percentage of each group reaching either a gestational age of 34w0d or documentation of fetal lung maturity at 32w0d to 33w6d. Secondary outcomes will include the latency period for each group and the percentage of newborns in each group who have major neonatal morbidity or death.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Preterm Delivery

Intervention

17-alpha-hydroxy-progesterone caproate, Castor Oil (Placebo)

Location

Desert Good Samaritan Hospital
Mesa
Arizona
United States
85202

Status

Not yet recruiting

Source

Obstetrix Medical Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:16-0400

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PubMed Articles [7394 Associated PubMed Articles listed on BioPortfolio]

Erratum to: A Double-Blind, Randomized, Placebo-Controlled Trial of 17 Alpha-hydroxyprogesterone Caproate in the Management of Preterm Premature Rupture of Membranes.

Plasma progesterone, estradiol, and unconjugated estriol concentrations in twin pregnancies: Relation to cervical length and preterm delivery.

The aim was to examine the association between plasma hormone concentrations, cervical length and preterm delivery in twin pregnancies, including the effect of progesterone treatment.

The association between serum progesterone level and preterm delivery.

To investigate the association of serum progesterone level and preterm delivery.

Effect on endometrial histology and pharmacokinetics of different dose regimens of progesterone vaginal pessaries, in comparison with progesterone vaginal gel and placebo.

Which progesterone vaginal pessary dose regimen induces adequate secretory transformation of the endometrium, in comparison with progesterone vaginal gel and placebo?

Adjuvant 17-hydroxyprogesterone caproate in women with history-indicated cerclage: A systematic review and meta-analysis.

To evaluate whether there are additional benefits of 17-hydroxyprogesterone caproate (17-OHPC) supplementation in preventing recurrent spontaneous preterm birth in women with a prophylactic cerclage.

Medical and Biotech [MESH] Definitions

A biologically active 20-alpha-reduced metabolite of PROGESTERONE. It is converted from progesterone to 20-alpha-hydroxypregn-4-en-3-one by the 20-ALPHA-HYDROXYSTEROID DEHYDROGENASE in the CORPUS LUTEUM and the PLACENTA.

A long-acting potent progestogen structurally related to PROGESTERONE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1185)

An enzyme that catalyzes the reduction of a 3 beta-hydroxy-delta(5)-steroid to 3-oxo-delta(4)-steroid in the presence of NAD. It converts pregnenolone to progesterone and dehydroepiandrosterone to androstenedione. EC 1.1.1.145.

Common name for Ricinus communis, a species in the family EUPHORBIACEAE. It is the source of CASTOR OIL.

A biologically active 5-alpha-reduced metabolite of plasma PROGESTERONE. It is the immediate precursor of 5-alpha-pregnan-3-alpha-ol-20-one (ALLOPREGNANOLONE), a neuroactive steroid that binds with GABA(A) RECEPTOR.

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