Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length

Preterm Birth Clinical Trial

Official title:

Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02746900
• Other study ID #: 100/16
• Status: Recruiting
• Phase: Phase 4
• First received: April 8, 2016
• Last updated: April 18, 2016
• Start date: April 2016
• Est. completion date: April 2019

Study information

• Verified date: April 2016
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB.

Different strategies have been adopted for prevention of SPTB. Growing interest has focused on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use, does not require anesthesia, can be used in an outpatient clinic setting, and it is easily removed when necessary. However, a recent systematic review and meta-analysis of randomized clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of women with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7 However, even if the statistical significance were not reached, they found a reduction in SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15).

Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without prior SPTB.

Description:

Investigators aim to conduct a prospective, multicenter, randomized, open-label, clinical trial at Department of Reproductive Science, University of Naples Federico II. All women included in the study will provide a written informed consent to participate in the study before the randomization.

Women with TVU CL ≤25mm who will meet the inclusion criteria will be counselled by an obstetrician regarding the risk of SPTB as per standard of care. The patient will be given ample time to have all questions addressed and consider participation. If the patient agrees to participate in the study, the informed consent form will be signed and a copy will be given to the patient. Women who are eligible and consent to participate in the study will be randomly assigned to one of two groups: cervical cerclage (i.e. intervention group) or standard obstetric management (i.e. control group).

Investigators planned subgroup analyses according to different CL cutoffs (i.e. <=15 and <=10 mm); type of suture; and according to prior history of cervical surgery (i.e. LEEP or cone biopsy).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 587
• Est. completion date: April 2019
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18-50 ages

• Singleton pregnancy

• Cervical length <=25mm between 18(0) and 23(6) weeks

Exclusion Criteria:

• Multiple pregnancy

• Prior spontaneous preterm birth or second trimester losses between 16(0) and 36(6) weeks

• Cerclage in situ

• Painful regular uterine contraction and/or preterm labor

• Ruptured membranes

• Major fetal defects

• Active vaginal bleeding

• Placenda previa and/or accreta

• Cervical dilation >1.5 cm and/or visible membranes by pelvic exam

• Suspicion of chorioamnionitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Procedure:
• Cervical cerclage
McDonald cervical cerclage

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spontaneous preterm birth (SPTB)		Less than 35 weeks gestation	No
Secondary	Spontaneous preterm birth (SPTB)		Less than 37,34,32,28 and 24 weeks gestation	No
Secondary	Gestational age at delivery	mean gestational age at delivery in weeks	Delivery (at birth)	No
Secondary	Latency	mean latency in days (from randomization to delivery)	Delivery (at birth)	No
Secondary	chorioamnionitis	chorioamnionitis histologically proven	Delivery (at birth)	No
Secondary	Birth weight	in grams	Delivery (at birth)	No
Secondary	Admission to neonatal intensive care unit		Delivery (at birth)	No
Secondary	respiratory distress syndrome		Delivery (at birth)	No
Secondary	low birth weight	birth weight <2500 grams	Delivery (at birth)	No
Secondary	intraventricular hemorrhage	grade 3 or 4	Between birth and 28 days of age	No
Secondary	neonatal mortality	death of a live-born baby within the first 28 days of life	Between birth and 28 days of age	No