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
Not provided
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.
Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.
This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micronized progesterone 400 mg | Experimental | participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day) |
|
| No treatment | No Intervention | No treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micronized progesterone 400 mg (Utrogestan) | Drug | participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The mean number of days from enrollment to delivery | Up to 18 weeks | |
| The rate of preterm spontaneous delivery | defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation | Up to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation | Up to 13 weeks | |
| Pregnancy prolongation beyond one week | Up to 18 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria
Contraindication to ongoing pregnancy including:
Major fetal malformation
Known maternal allergy to progesterone
Current use of progesterone at the time of admission
Epilepsy
Breast cancer
PPROM (preterm premature rupture of membranes) during testing for eligibility
Age below 18 years
Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)
History of deep vein thrombosis
Major active psychiatric disorders (major affective disorders and psychotic disorders)
Uncontrolled chronic hypertension
Heart failure
Chronic renal failure
Pre-gestational diabetes with known target organ damage
History of spontaneous preterm delivery
Previous tocolytic treatment during the current pregnancy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poriya Medical Center | Tiberias | North | 15208 | Israel | ||
| Emek Medical center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38976270 | Derived | Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Need for repeated acute tocolysis | Up to 13 weeks |
| Number of hospitalizations and length of stay until 36.6 gestational weeks | Up to 13 weeks |
| The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation) | Up to 13 weeks |
| Admission to the NICU (neonatal intensive care unit) | From delivery and up to 28 days |
| Length of NICU stay | From delivery and up to 3 months |
| Length of neonate hospital stay | From delivery and up to 3 months |
| Fetal/neonatal death | Around delivery |
| Birth weight and the rate of small for gestational age neonates | Around delivery |
| The rate of neonatal complications | including transient tachypnea, RDS (respiratory distress syndrome), bronchopulmonary dysplasia, ventilatory support, supplemental oxygen, IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), PDA (patent ductus arteriosus), retinopathy, neonatal sepsis, and congenital abnormalities not previously identified (specifically genital abnormalities). | From delivery and up to 3 months |
| The rate of chorioamnionitis and endometritis | around delivery and up to 1 week post-partum |
| Adverse medication reactions | Up to 13 weeks |
| Postpartum hemorrhage | From delivery and up to 1 week post-partum |
| Revision of uterine and cervix and reasons for the procedure | During the 48 hours from delivery |
| Urinary tract or vulvovaginal infection until 36.6 weeks | Up to 13 weeks |
| Afula |
| Please Select |
| 18100 |
| Israel |
| Assuta Ashdod medical center | Ashdod | Israel |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |