NL-OMON26394
Not yet recruiting
Not Applicable
Pessary or Progesterone to Prevent Preterm birth in women with short cervical length
Academic Medical Center Amsterdam0 sites1,020 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstretic labor, prematurePessariesProgesteroncervical lengthPrevention
- Sponsor
- Academic Medical Center Amsterdam
- Enrollment
- 1020
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
one
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less (\=35mm) OR
- •2\. Multiple pregnancy and cervical length at 16 to 22 weeks of less than 38 mm (\<38mm)
Exclusion Criteria
- •1\. Cervical cerclage in this pregnancy
- •2\. Maternal age less than 18 years
- •3\. Identified major congenital abnormalities
- •4\. Death of one or both of the foetuses
- •5\. Previous spontaneous preterm birth before 34 weeks
- •6\. Participation Quadruple P study in previous pregnancy
- •7\. Cervical length \< 2 mm
- •8\. Cervical dilation \>3cm
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 3
Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length.preterm birth10028920NL-OMON50366Academisch Medisch Centrum960
Active, not recruiting
Phase 1
Pessary or Progesterone to Prevent Preterm delivery in women with short cervical lengthpreterm birthMedDRA version: 20.1Level: LLTClassification code 10023555Term: Labour prematureSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.1Level: LLTClassification code 10023545Term: Labor prematureSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.0Level: LLTClassification code 10036594Term: Premature birthSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.1Level: PTClassification code 10036600Term: Premature labourSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsMedDRA version: 20.1Level: LLTClassification code 10036599Term: Premature laborSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditionsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]EUCTR2013-002884-24-NLAMC960
Recruiting
Not Applicable
Quadruple-P follow-up<p>Women with short cervical length during mid-trimester, therefore having a highrer risk on preterm birth</p>NL-OMON26646one600
Recruiting
Not Applicable
Pessary (cervical Ring) plus Progesterone to prevent Preterm deliveryRBR-3t8przIVERSIDADE ESTADUAL DE CAMPINAS
Active, not recruiting
Phase 1
PEPPER-trialPlacenta previa, preterm birthTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]CTIS2023-507763-18-01Amsterdam UMC142