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Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03837288
Enrollment
60
Registered
2019-02-12
Start date
2019-04-22
Completion date
2019-10-22
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labor, Cervical Incompetence

Keywords

preterm labor, cerclage

Brief summary

The aim of this study is to Determine whether cerclage with vaginal progesterone will: 1. Reduce the overall spontaneous preterm birth rate. 2. Prolong pregnancy latency. 3. Improve neonatal outcome. Compared to vaginal progesterone only, in patients with progressive cervical shortening. Research question: Does cervical cerclage reduce the overall spontaneous preterm births in patients with progressive cervical shortening. Research Hypothesis In this current study, the investigators hypothesize that cervical cerclage reduces spontaneous preterm births in patients with progressive cervical shortening on vaginal progesterone only.

Detailed description

A randomized controlled trial The study will be done in Ain Shams University Hospital including women attending antenatal care clinic in Ain Shams University Hospital. All patients entering the trial will be counselled and will sign a written consent explaining the details of the trial. All the patients included in this study will undergo routine Fetal anomaly scan at 18-24 weeks.Patients with cervical length \< 20 mm in routine anomaly scan will : 1. Receive vaginal progesterone suppositories 200 mg daily.. (All patients will be continued with vaginal progesterone until 37 completed weeks or until they develop preterm rupture of membrane or preterm delivery). 2. Undergo routine follow up of cervical length every 1 to 2 weeks. Patients with progressive shortening of cervical length less than 10 mm during routine follow up, will have the option of continuing vaginal progesterone daily (Progesterone 200 mg vaginal suppositories) alone, or having cervical cerclage placed in addition to daily vaginal progesterone. In cerclage group: all patients will sign a written consent for approval of cervical cerclage.

Interventions

PROCEDURECerclage

Cervical cerclage under effect of spinal anaesthesia

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

1. Women aged: 20-38 years old. 2. Single living fetus. 3. The patient does not have history of preterm labor (before 37 weeks of gestation) 4. No history of cervical or uterine anomalies.

Exclusion criteria

1. Congenital anomalies in the fetus discovered during the follow up. 2. History of spontaneous preterm births. 3. Evidence of imminent delivery, or uterine contractions. 4. Evidence of rupture of membranes, or intra amniotic infection. 5. Intra uterine fetal death. 6. Uterine or cervical anomalies.

Design outcomes

Primary

MeasureTime frameDescription
Gestational age of delivery<37 weeksAfter 37 weeks of pregnancy

Secondary

MeasureTime frameDescription
New born birth weightAt time of birthless than 2 kg

Countries

Egypt

Contacts

Primary ContactManal Fawzy
manoly18loly@gmail.com01012659658
Backup ContactAl Hassan Khedr
Hasankhedr@gmail.com01006193797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026