Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length

Phase 1

• Conditions: preterm birth; MedDRA version: 20.1Level: LLTClassification code 10023555Term: Labour prematureSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.1Level: LLTClassification code 10023545Term: Labor prematureSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: LLTClassification code 10036594Term: Premature birthSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.1Level: PTClassification code 10036600Term: Premature labourSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.1Level: LLTClassification code 10036599Term: Premature laborSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-002884-24-NL
• Lead Sponsor: AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-05
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 960

Inclusion Criteria

1. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less
2. Twin pregnancy and cervical length at 16 to 22 weeks of 38 mm or less

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1020
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Cervical cerclage in this pregnancy
2. Maternal age less than 18 years
3. Identified major congenital abnormalities in this pregnancy
4. Death of one or both of the foetuses in this pregnancy
5. Spontaneous preterm birth before 34 weeks in previous pregnancy
6. Participation Quadruple P study in previous pregnancy
7. Cervical length less then 2mm
8. Cervical dilatation of 3cm or more

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effectiveness of vaginal progesterone and cervical pessary in the prevention of preterm birth in women with singleton and twin pregnancies and a short cervix. ;Secondary Objective: not applicable;Primary end point(s): Primary outcome is composite adverse neonatal outcome. This composite outcome contains periventricular leukomalacia (PVL) > grade 1, severe respiratory distress syndrome (RDS) bronchopulmonary Dyplasia (BPD), Intraventricular Haemorrhage grade II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis, stillbirth and death before discharge from the nursery.;Timepoint(s) of evaluation of this end point: Information will be gathered when pregnancy has finished and the child is discharged.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal and admission days for preterm labour and costs. Follow up of the children will be planned depending on the outcome of the trial. ;Timepoint(s) of evaluation of this end point: Information will be gathered when pregnancy has finished and the child is discharged.<br>After the corrected age of 2 years information on long term follow-up will be collected.