Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) (17PinPROM)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01119963 |
|
Recruitment Status :
Completed
First Posted : May 10, 2010
Results First Posted : May 30, 2018
Last Update Posted : June 28, 2018
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
The objective of the study is to determine if a weekly dose of 17 hydroxyprogesterone caproate (17P, Makena®) given to women with preterm rupture of the membranes will:
- increase the probability of continuing the pregnancy until a favorable gestational age.
- increase the interval between randomization and delivery.
- decrease neonatal morbidity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Preterm Delivery | Drug: 17-alpha-hydroxy-progesterone caproate, Makena® Drug: Castor Oil (Placebo) | Phase 2 Phase 3 |
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 17 hydroxyprogesterone caproate (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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 152 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | 17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | October 2014 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: 17-alpha hydroxyprogesterone caproate, Makena®
250 mg of 17P, Makena® intramuscular (IM) weekly.
|
Drug: 17-alpha-hydroxy-progesterone caproate, Makena®
Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
Other Names:
|
|
Placebo Comparator: Placebo
Castor Oil (Placebo)intramuscular (IM) weekly
|
Drug: Castor Oil (Placebo)
IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
Other Names:
|
- Gestational Age at Delivery [ Time Frame: Measured from day of last menstrual cycle to day of birth and measured in weeks. ]Gestational age is measured in weeks, from the first day of the woman's last menstrual cycle to the date the baby was born.
- Duration of Latency Period [ Time Frame: average number of days measured from day of study entry until day of delivery ]
Secondary Outcomes:
- Duration of latency period (time from randomization to birth)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participant is 18 years old or older
- Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
- Singleton pregnancy
- PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnisure® test (c) Two or more of (i) through (iv): i. Nitrazine test with pH of 7 or more ii. Positive fern test iii. Gross pooling of clear fluid iv. US exam showing oligohydramnios
Exclusion Criteria:
- Any contraindication to expectant management
- Any fetal condition likely to cause serious neonatal morbidity independent of gestational age
- History of allergy to 17P
- Any contraindications to 17P use (e.g. Thrombosis, Breast CA, abnormal vaginal bleeding unrelated to pregnancy, jaundice, liver disease, uncontrolled HTN)
- Any medical condition currently treated with systemic steroid medications
- Cervical cerclage present at the time of PROM
- Informed consent not obtained.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119963
| United States, Alabama | |
| University of South Alabama Medical Center | |
| Mobile, Alabama, United States, 36617 | |
| United States, Arizona | |
| Desert Good Samaritan Hospital | |
| Mesa, Arizona, United States, 85202 | |
| Banner Good Samaritan Hospital | |
| Phoenix, Arizona, United States, 85006 | |
| Tucson Medical Center | |
| Tucson, Arizona, United States, 85712 | |
| United States, California | |
| Long Beach Memorial Medical Center | |
| Long Beach, California, United States, 90801-1428 | |
| Good Samaritan Hospital | |
| San Jose, California, United States, 95124 | |
| OConnor Hospital | |
| San Jose, California, United States, 95128 | |
| United States, Colorado | |
| Swedish Medical Center | |
| Denver, Colorado, United States, 80110 | |
| Presbyterian/St Luke's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Kentucky | |
| Norton Kosair Children's Hospital | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Michigan | |
| Spectrum Health Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Missouri | |
| Saint Luke's Hospital, Kansas City | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nevada | |
| Sunrise Medical Center | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0526 | |
| United States, Washington | |
| Swedish Medical Center | |
| Seattle, Washington, United States, 98122-4307 | |
| Principal Investigator: | Andrew Combs, MD | Obstetrix Medical Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Obstetrix Medical Group |
| ClinicalTrials.gov Identifier: | NCT01119963 |
| Other Study ID Numbers: |
OBX0012 |
| First Posted: | May 10, 2010 Key Record Dates |
| Results First Posted: | May 30, 2018 |
| Last Update Posted: | June 28, 2018 |
| Last Verified: | May 2018 |
|
Preterm delivery |
|
Premature Birth Rupture Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Wounds and Injuries Castor Oil Progesterone 17 alpha-Hydroxyprogesterone Caproate |
11-hydroxyprogesterone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Estrogen Antagonists Hormone Antagonists Cathartics Gastrointestinal Agents |