Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.
After taking informed written consent, the recruited patients will be subjected to the following:
Detailed history
Examination of the patients General examination: blood pressure, pulse, temperature
Abdominal examination:
Inspection: fundal level, scars, umbilicus.
Palpation: presence of contractions, fetal lie and presentation.
Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
Non stress test to ensure reassuring fetal well being
Ultrasound examination to:-
Baseline laboratory investigations:
The included patients were randomized using sealed opaque envelope method into one of two groups:
Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.
Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Active Comparator | 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection |
|
| control group | Placebo Comparator | castor oil, 1 mL total volume intramuscular injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17-hydroxyprogesterone caproate | Drug | intramuscular injection weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| prolongation of the pregnancy until a favorable gestational age | The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used | 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.) |
| Measure | Description | Time Frame |
|---|---|---|
| Latency . | The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used | 10 to 12 weeks (interval in weeks from randomization to delivery) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
Non reassuring fetal status or fetal distress
Presence of fetal anomalies incompatable with life
Woman with antepartum haemorrhage
Diagnosis of Established preterm labor
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | 11591 | Egypt |
Not provided
starting 6 months after publication
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000077713 | 17 alpha-Hydroxyprogesterone Caproate |
| D002368 | Castor Oil |
| ID | Term |
|---|---|
| D019326 | 17-alpha-Hydroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Castor Oil |
| Drug |
intramuscular injection weekly |
|
| Composite neonatal morbidity |
by Apgar score ,blood gases ,and labs |
| 1 week (from delivery to 1 week post Natal) |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005224 | Fats, Unsaturated |
| D005223 | Fats |
| D008055 | Lipids |
| D010938 | Plant Oils |
| D009821 | Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |