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Clinical Trials/ISRCTN11186205
ISRCTN11186205
Completed
Not Applicable

Three-arm randomised trial of cervical cerclage, arabin pessary and vaginal progesterone to prevent spontaneous preterm birth in asymptomatic women at high-risk of preterm birth: A feasibility study

niversity of Liverpool (UK)0 sites39 target enrollmentMarch 10, 2016
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ConditionsTopic: Reproductive HealthSubtopic: Reproductive Health & Childbirth (all Subtopics)Disease: Reproductive Health & ChildbirthPregnancy and ChildbirthPreterm birth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Topic: Reproductive Health
Sponsor
niversity of Liverpool (UK)
Enrollment
39
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 10, 2016
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
niversity of Liverpool (UK)

Eligibility Criteria

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
  • •5\. Cervical length at least \<3rd centile for gestational age
  • •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\)

Outcomes

Primary Outcomes

Not specified

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