Stitch, progesterone or pessary: a randomised controlled trial

Not Applicable

Completed

• Conditions: Prevention of preterm birth in women with a short cervix; Pregnancy and Childbirth

• Registration Number: ISRCTN13364447
• Lead Sponsor: Guy's and St. Thomas' NHS Foundation trust

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39012912/ (added 17/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-29
• Study Completion: 2021-07-01
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 540

Inclusion Criteria

Women with singleton pregnancies who are found to have cervical length <25 mm on transvaginal ultrasound between 14+0 weeks’ gestation (dated by ultrasound or LMP and adjusted for ultrasound estimated date of delivery once ultrasound performed if no miscarriage prior to dating ultrasound) until 23+6 weeks’ gestation and one or more of the following risk factors
1. Written informed consent to participate
2. History of:
2.1. Previous preterm premature rupture of the fetal membranes (= 37 weeks’)
2.2 History of previous PTB/second trimester loss (= 16 weeks’ or = 37 weeks’ gestation)
2.3. Any cervical procedure to treat abnormal smears i.e. large loop excision, laser conisation, cold knife conisation or radical diathermy
3. Incidental finding of a short cervix on ultrasound scan (e.g. at the time of anomaly scan)
4. Women aged 18-50

Exclusion Criteria

1. Women with persistent fresh vaginal bleeding evident on speculum examination.
2. Women with visible membranes evident on speculum examination or open cervix on ultrasound scan.
3. Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
4. Known significant congenital or structural or chromosomal fetal abnormality.
5. Suspected or proven rupture of the fetal membranes at the time of recruitment.
6. Women currently using progesterone pessaries or who have taken progesterone beyond 18 weeks gestation.
7. Women who have a cervical suture in situ.
8. Women who already have a cervical pessary in situ.
9. Insufficient understanding of the trial in the opinion of the Investigator
10. If the attending clinician feels that an individual woman is more suited to one treatment modality over another
11. Any contraindications or cautions to the investigational medicinal product including:
11.1. Known allergy or hypersensitivity to progesterone
11.2. Hepatic dysfunction
11.3. Undiagnosed vaginal bleeding
11.4. Mammary or genital tract carcinoma
11.5. Thrombophlebitis
11.6. Thromboembolic disorders
11.7. Cerebral haemorrhage
11.8. Porphyria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preterm birth prior to 37 weeks; Timepoint(s): <37 weeks gestation