Preterm LaborNCT03837288
Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
A study testing Cerclage in people with Preterm Labor and Cervical Incompetence, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor, Cervical Incompetence
- What is being tested?
- Cerclage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2019to 22 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged: 20-38 years old.
- Single living fetus.
- The patient does not have history of preterm labor (before 37 weeks of gestation)
- No history of cervical or uterine anomalies.
Who cannot join
- Congenital anomalies in the fetus discovered during the follow up.
- History of spontaneous preterm births.
- Evidence of imminent delivery, or uterine contractions.
- Evidence of rupture of membranes, or intra amniotic infection.
- Intra uterine fetal death.
- Uterine or cervical anomalies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AinshamsU
Cairo, +02
Manal Fawzy, Bachalori, 01012659658, manoly18loly@gmail.com
Al Hassan Khedr, MD, 01006193797, hasankhedr@gmail.com
About this study
The aim of this study is to
Determine whether cerclage with vaginal progesterone will:
- Reduce the overall spontaneous preterm birth rate.
- Prolong pregnancy latency.
- 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.
Read the 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 :
- 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).
- 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.
- Conditions
- Preterm Labor, Cervical Incompetence
- Being tested
- Cerclage
- Keywords
- preterm labor, cerclage
- Medical subject headings
- Obstetric Labor, Premature, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CerclageProcedure or surgery
Cervical cerclage under effect of spinal anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone only | No intervention | continue on vaginal progesterone only |
| Cervical cerclage plus vaginal progesterone | Experimental | cerclage with vaginal progesterone. Receives: Procedure: Cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age of delivery
After 37 weeks of pregnancy
Measured: <37 weeks
Secondary outcomes (1)
New born birth weight
less than 2 kg
Measured: At time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start22 Apr 2019 (estimated)
- Primary completion20 Sep 2019 (estimated)
- Study completion22 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Mohammed Fawzy, Ain Shams University
- Investigators
- Yasser Shahawy, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03837288
- Sponsor's protocol ID
- Trial
- Status last verified
- Feb 2019
- First submitted
- 8 Jan 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.
PubMed 32970845
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cerclage for Singleton Pregnant on Vaginal Progesterone With Progressive Cervical Length Shortening
- ClinicalTrials.gov ID
- NCT03837288
- Acronym / sponsor ID
- Trial
- Conditions
- Preterm Labor, Cervical Incompetence
- Keywords
- preterm labor, cerclage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Apr 2019 (estimated)
- Primary completion
- 20 Sep 2019 (estimated)
- Study completion
- 22 Oct 2019 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to
Determine whether cerclage with vaginal progesterone will:
- Reduce the overall spontaneous preterm birth rate.
- Prolong pregnancy latency.
- 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 :
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone only | No intervention | –continue on vaginal progesterone only |
| Cervical cerclage plus vaginal progesterone | Experimental | Procedure: Cerclagecerclage with vaginal progesterone. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged: 20-38 years old.
- Single living fetus.
- The patient does not have history of preterm labor (before 37 weeks of gestation)
- No history of cervical or uterine anomalies.
Key exclusion criteria (6 listed)
- Congenital anomalies in the fetus discovered during the follow up.
- History of spontaneous preterm births.
- Evidence of imminent delivery, or uterine contractions.
- Evidence of rupture of membranes, or intra amniotic infection.
- Intra uterine fetal death.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CerclageCervical cerclage under effect of spinal anaesthesia | Procedure or surgery | Cervical cerclage plus vaginal progesterone |
Primary outcome
Gestational age of delivery
Time frame: <37 weeks
After 37 weeks of pregnancy
1 secondary outcome
New born birth weight
Time frame: At time of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Derived from this study: PubMed 32970845Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.
- Individual participant dataSharing planned: Undecided
Related trials for Preterm Labor
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasser Shahawy study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerclage in people with Preterm Labor and Cervical Incompetence, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manal Fawzy (01012659658, manoly18loly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age of delivery (time frame: <37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03837288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.