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Eligible patients will be informed and asked to enroll in the study at hospital admission. A transvaginal ultrasound examination will be performed to determine cervical length. If an eligible woman accepts to participate, patient will be randomized to one of the study arms assigned in a double blind basis. Patient will receive the medication (vaginal capsule of progesterone or placebo). The patient will administer herself one vaginal capsule in a daily basis since gestational age of 36 weeks and 6 days as the primary endpoint is to demonstrate that the use of a maintenance treatment with vaginal progesterone is able to reduce the incidence of preterm birth before 34.0 and 37.0 gestational weeks. After delivery, perinatal and neonatal data will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Progesterone 200 mg |
|
| B | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | 1 vaginal capsule, 200 mg, once daily since gestation age 36 weeks and 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of deliveries before week 34 of gestation | week 34 of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Median time from randomization to delivery | delivery | |
| Ultrasound cervical length | week +5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Montse Palacio, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Son Llàtzer | Palma de Mallorca | Balearic Islands | 07198 | Spain | ||
| Institut Universitari Dexeus |
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo |
| Drug |
1 vaginal capsule, once daily since gestational age of 36 weeks and 6 days |
|
| Barcelona |
| Barcelona |
| 08028 |
| Spain |
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| Hospital Sant joan de Déu de Manresa | Manresa | Barcelona | 08243 | Spain |
| Corporació Sanitària Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Terrassa. CST | Terrassa | Barcelona | 08227 | Spain |
| Hospital de Basurto | Bilbao | Bilbao | 48013 | Spain |
| Hospital Puerta del Mar | Cadiz | Cádiz | 11009 | Spain |
| Complejo Hospitalario Universitario Insular-Materno Infantil | Las Palmas de Gran Canaria | Gran Canaria | 35016 | Spain |
| Hospital U Gregorio Marañon | Madrid | Madrid | 28009 | Spain |
| Hospital Virgen de la Macarena | Seville | Seville | 41009 | Spain |
| Hospital Clinico U. Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| 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 |