Prevention of preterm birth

Completed

• Conditions: Topic: Reproductive Health; Subtopic: Reproductive Health & Childbirth (all Subtopics); Disease: Reproductive Health & Childbirth; Pregnancy and Childbirth; Preterm birth

• Registration Number: ISRCTN11186205
• Lead Sponsor: niversity of Liverpool (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-10
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

1. Aged 18 years or older
2. Singleton pregnancy
3. Between 16+0 – 24+6 weeks in current pregnancy
4. History of previous spontaneous preterm birth (sPTB) or premature rupture of membranes (PPROM) between 16-33+6
AND
5. Cervical length at least <3rd centile for gestational age
OR
6. History of significant cervical surgery defined as two large loop excision of the transformation zone (LLETZ) procedures or a single knife cone biopsy (KCB) where a clinical decision is made to treat the short cervix
7. Clinical equipoise as to what is the best treatment

Exclusion Criteria

1. Known or suspected structural or chromosomal fetal abnormality
2. Inability to give informed consent
3. Treatment with history indicated cerclage
4. Treatment with vaginal progesterone within two weeks of randomisation
5. All contraindications to use of progesterone (see protocol 6.2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility is measured at 12 months post recruitment, with follow up until final mother and baby discharge or 6 weeks postnatal.

Secondary Outcome Measures

Name	Time	Method
1. Economic analysis is completed at 12 months post recruitment<br>2. Patient and staff acceptability is measured 1-2 months post study completion