The Use of Progesterone to Reduce Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Weeks Gestation at Birth Among Patients Receiving the Active Drug.
研究概览
简要总结
Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that giving progesterone (a normal hormone made by the ovaries) prolongs gestation in women who have had a preterm birth in an earlier pregnancy (and therefore are at risk for another early delivery). There are other studies that show that this technique of giving a weekly shot of progesterone does not prevent preterm birth. In addition, There are other groups of patients who are at very high risk for preterm birth which have not been studied. They include: 1.) Cervical cerclage (a stitch in the mouth of the womb); 2.) Multifetal gestation (twins, triplets, etc.); 3.) Women with preterm (<34 weeks) rupture of the membranes; 4.) Women with preterm labor during the current pregnancy with intact membranes who have been tocolyzed (have their labor stopped and are getting ready to go home). We purpose to give weekly shots of progesterone or a placebo in a randomized fashion to women in the first group who are at risk for preterm delivery due to an early birth in a previous pregnancy as well as the other four groups listed. If progesterone given weekly is successful at preventing early delivery as compared to the placebo group then great benefit for these women as well as future pregnancies would be accrued.
详细描述
A. Introduction Preterm birth occurs in 7-12% of all deliveries, but accounts for over 85% of all perinatal morbidity and mortality.1 Despite many strategies for reducing the incidence of preterm birth none have been totally effective. One treatment that showed promise in earlier small trials was the prophylactic administration of progestational compounds.2,3 However, the reports of efficacy were mixed with some showing benefits4,5 while others did not.6,7 More recently, two randomized clinical trials have shown great promise8,9, and revealed a significant decrease in preterm births among women who received 17 alpha-hydroxyprogesterone caproate (17P)8, or 100mg of progesterone delivered by vaginal suppository per week.9 Indeed support by the American College of Obstetricians and Gynecologists, and March of Dimes as well as others have made this treatment the standard of care in many areas of the country.
The limitations of these studies are that they have small numbers as well as a higher than expected preterm delivery rate among placebo patients. Because of the previous controversy as to the effectiveness of progesterone noted in the 70's - 80's it is incumbent upon other centers to carry out new investigational trials in an effort to confirm their results. Secondly, the studies were limited to singleton pregnancies who were "at risk" for preterm delivery thus not surveying three groups with the highest preterm delivery rate: 1.) Multifetal gestations and cervical insufficiency; 2.) Those who have preterm labor in the current pregnancy that have been tocolyzed; 3.) Women with preterm premature rupture of the membranes.
The purpose of the current study to confirm if possible, the findings of the most recent investigations8,9 using the same patient population and in addition, we will study the effect of progesterone vs placebo in preventing early delivery among multifetal gestations in women who have been diagnosed with preterm labor in the current pregnancy.
B. Specific Aim The aim of this study is to compare progesterone (100mg progesterone weekly) to ascertain if there is a reduction in preterm birth and subsequent neonatal morbidity among patients receiving the active drug. If weekly treatment with this agent can be shown to reduce the incidence of preterm delivery and its surrogate adverse outcomes in the neonate, it will have major impact upon patients and the health care delivery system.
C. Rationale Progesterone as indicated in the Introduction has been shown in some, but not all, studies to reduce incidence of preterm delivery and the adverse effects of prematurity. Progesterone has been shown to reduce the number of oxytocin receptors in the myometrium and be responsible in the near term pregnant women for blocking the onset of labor. Weekly use of this compound, if effective, would be much superior to the tocolytic agents currently available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnancy 20 - 34 weeks; cervical dilation <4 cm; risk for preterm birth; multifetal gestation; diagnosis of preterm labor during the current pregnancy effectively tocolyzed); preterm rupture of the fetal membranes (24 - 34 weeks); willing and able to sign Informed Consent Form
排除标准
- •Failure to meet inclusion criteria as noted above; contraindication to pregnancy continuation; severe medical diseases such as sickle cell disease with crises, diabetes mellitus (F/R/H), severe preeclampsia etc., (physician judgment; severe fetal/obstetric criteria such as intrauterine growth restriction (<5th percentile, placental abruption,placental previa, etc., (physician judgment); non reassuring fetal assessment; allergy to progesterone compounds; refusal to participate
研究组 & 干预措施
1 Placebo
The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
干预措施: Placebo (Drug)
Progesterone
The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
干预措施: Progesterone (OHP17) (Drug)
结局指标
主要结局
Weeks Gestation at Birth Among Patients Receiving the Active Drug.
时间窗: Through delivery, until discharge up to 40 weeks gestation
Weeks gestation at birth, the interval to delivery, or neonatal morbitity.
次要结局
未报告次要终点
研究者
John Morrison
Professor, Ob-Gyn
University of Mississippi Medical Center