Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099164
Status:
COMPLETED
Last Update Posted:
2019-02-21
First Post:
2004-12-08
Brief Title:
Trial of Progesterone in Twins and Triplets to Prevent Preterm Birth STTARS
Sponsor:
The George Washington University Biostatistics Center
Organization:
The George Washington University Biostatistics Center
Study Overview
Official Title:
A Randomized Trial of 17 Alpha-Hydroxyprogesterone Caproate for Prevention of Preterm Birth in Multifetal Gestation STTARS
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women pregnant with twins or triplets are at high risk of preterm birth yet no intervention or approach has served to reduce this risk A recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units MFMU Network has for the first time demonstrated a treatment that substantially reduces the rate of preterm birth in women at high risk for preterm delivery ie progesterone therapy Preterm birth was reduced by 35 among progesterone-treated women with a singleton pregnancy when compared with women receiving placebo The current trial compares weekly treatment by injection of progesterone with placebo in women pregnant with twins or triplets
Detailed Description:
Women with multifetal gestation face numerous risks in excess of those faced by women with singleton gestation Preterm birth is by far the most common and the most significant of these problems yet no intervention or approach has served to reduce this risk The prevalence of preterm birth has risen dramatically in recent years in large part due to Assisted Reproductive Technologies Consequently the problem of preterm birth has assumed an even greater role in contributing to perinatal morbidity and mortality The recently completed trial by the NICHD sponsored Maternal Fetal Medicine Units MFMU Network has for the first time demonstrated a treatment ie progesterone therapy that substantially reduces the rate of preterm birth in women at high risk for preterm delivery because of a prior spontaneous preterm birth Preterm birth was reduced by 35 among progesterone-treated women when compared with women receiving placebo Given this dramatic benefit and the extremely high risk of preterm birth in women with multifetal gestation a trial to evaluate the benefit of progesterone in women with multifetal pregnancy is appropriate and timely This protocol outlines a randomized double-masked clinical trial comparing weekly treatment by injection of 17 alpha-hydroxyprogesterone caproate 17P with placebo in women with twin or triplet gestation In an ancillary study the pharmacokinetics and pharmacodynamics of 17P in multifetal gestation will be studied
This trial aims to enroll six hundred women with twin gestation and one hundred twenty women with triplet gestation between 16 weeks 0 days to 20 weeks 6 days At the initial screening evaluation and after signing the informed consent form the patient will receive an injection of the placebo 1 ml inert castor oil She will be asked to return after three days for randomization During this compliance test period an ultrasound exam will be scheduled if not previously done When the patient returns and if she still meets the inclusion criteria she will be randomized to one of two treatments
17 a-hydroxyprogesterone caproate weekly 1 ml injections containing 250 mg of 17P
Placebo weekly injections of 1 ml placebo inert castor oil
Treatment will be given through 34 weeks 6 days gestation or delivery At the time of consent to the main study the patient will also be asked to participate in an ancillary study If she agrees she will have 30 cc of blood drawn at 24-28 weeks and at 32-35 weeks gestation A pelvic exam will be done at the same two times to collect vaginal specimens and to determine Bishop score
This trial aims to enroll six hundred women with twin gestation and one hundred twenty women with triplet gestation between 16 weeks 0 days to 20 weeks 6 days At the initial screening evaluation and after signing the informed consent form the patient will receive an injection of the placebo 1 ml inert castor oil She will be asked to return after three days for randomization During this compliance test period an ultrasound exam will be scheduled if not previously done When the patient returns and if she still meets the inclusion criteria she will be randomized to one of two treatments
17 a-hydroxyprogesterone caproate weekly 1 ml injections containing 250 mg of 17P
Placebo weekly injections of 1 ml placebo inert castor oil
Treatment will be given through 34 weeks 6 days gestation or delivery At the time of consent to the main study the patient will also be asked to participate in an ancillary study If she agrees she will have 30 cc of blood drawn at 24-28 weeks and at 32-35 weeks gestation A pelvic exam will be done at the same two times to collect vaginal specimens and to determine Bishop score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HD21410 | None | None | None |
| HD27869 | None | None | None |
| HD27917 | None | None | None |
| HD27860 | None | None | None |
| HD27915 | None | None | None |
| HD34208 | None | None | None |
| HD34116 | None | None | None |
| HD34136 | None | None | None |
| HD40500 | None | None | None |
| HD40485 | None | None | None |
| HD40544 | None | None | None |
| HD40545 | None | None | None |
| HD40560 | None | None | None |
| HD40512 | None | None | None |
| HD36801 | None | None | None |