Twin Pregnancy With Antenatal ProblemPhase 2NCT07319715
Cerclage and Progesterone for Twin Pregnancies
A Phase 2 study testing McDonald Cervical Cerclage and Vaginal Progesterone Therapy (VPT) in people with Twin Pregnancy With Antenatal Problem, run by Benha University at 1 site in Egypt.
Trial summary
Twin pregnancies face a high risk of complications, most notably preterm birth (delivery before 37 weeks), which is a major cause of infant death and illness globally. For women carrying twins who are identified as having a short cervical length (cervix measuring 25 millimeters or less), there is currently no single… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy With Antenatal Problem
- What is being tested?
- McDonald Cervical Cerclage and Vaginal Progesterone Therapy (VPT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2023to 14 Jun 2025
- Phase
- Phase 2
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type of Pregnancy: Women with confirmed twin pregnancy (TP).
- Cervical Length: Short cervical length (CL) defined as ≤25 mm.
- Timing of Diagnosis: Short cervix detected via transvaginal ultrasound (TVU) at 11-13 weeks + 6 days, or detected during bi-weekly follow-up exams until 23 weeks + 6 days.
- Consent: Participants willing to undergo randomization and comply with the follow-up protocol.
Who cannot join
- Multiple Gestation (High Order): Triplet or higher-order pregnancies.
- Fetal/Uterine Complications: Polyhydramnios, premature rupture of membranes (PPROM), or known uterine abnormalities.
- Acute Symptoms: Vaginal bleeding, fever, or signs of fetal distress.
- Maternal Comorbidities: Pre-existing or gestational hypertension, and diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Benha University
Banhā, Qalyubia Governorate, 13511
About this study
Official title: Combined Cervical Cerclage and Vaginal Progesterone May Readjust the Deregulated Cervicovaginal Fluid Inflammatory Milieu and Improve Outcomes of Twin Pregnant Women
Twin pregnancies face a high risk of complications, most notably preterm birth (delivery before 37 weeks), which is a major cause of infant death and illness globally. For women carrying twins who are identified as having a short cervical length (cervix measuring 25 millimeters or less), there is currently no single, highly effective preventative treatment. This study is a randomized clinical trial designed to determine if a combined therapy of Cervical Cerclage (a surgical stitch to support the cervix) and Vaginal Progesterone (a hormone medication) is more effective than standard care in preventing preterm birth and improving the overall health outcomes for both the mother and the babies. The trial will also investigate the biological basis of this effect by measuring specific inflammation markers (cytokines like Interleukin-1$\beta$, 6, 8, and Tumor Necrosis Factor-α) in the cervical fluid before and after the intervention, to see if the combined treatment helps to reduce harmful local inflammation.
- Conditions
- Twin Pregnancy With Antenatal Problem
- Being tested
- McDonald Cervical Cerclage, Vaginal Progesterone Therapy (VPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McDonald Cervical CerclageProcedure or surgery
The procedure involves exposing the cervix and grasping it with ring forceps. A purse-string suture using No. 1 or 2 braided or monofilament material is placed at the 12 o'clock position with a curved needle. The needle is inserted at the junction of the vaginal epithelium and the cervix, approximately 2 cm above the external os and distal to the vesicocervical reflection. After 5-6 cautious bites, the stitch is pulled tight to close the internal os. The suture is typically removed at 37 weeks of gestation, provided there is no labor or membrane rupture.
Vaginal Progesterone Therapy (VPT)Drug
Participants receive 100 mg vaginal progesterone inserts.
Dosage \& Frequency: One 100 mg insert administered twice daily.
Duration: The treatment continues until the onset of spontaneous labor or until the 37th week of pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cerclage (CC) | Active comparator | Participants in this arm undergo a McDonald cerclage technique. This involves placing a purse-string suture (No. 1 or 2 braided or monofilament) around the cervix to close the internal os. The suture is typically removed at 37 weeks of gestation. Receives: Procedure: McDonald Cervical Cerclage |
| Vaginal Progesterone Therapy (VPT) | Active comparator | Participants receive 100 mg vaginal progesterone inserts (e.g., Endometrin) administered twice daily. This treatment continues until spontaneous labor occurs or until the 37th week of pregnancy. Receives: Drug: Vaginal Progesterone Therapy (VPT) |
| Combined Therapy (CC/VPT) | Active comparator | Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above. Receives: Procedure: McDonald Cervical Cerclage; Drug: Vaginal Progesterone Therapy (VPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration
The proportion of patients who achieved a pregnancy duration of 37 weeks or more and/or significantly delayed delivery, reflecting the effectiveness of the administered treatment regimens (Cervical Cerclage, Vaginal Progesterone, or Combined Therapy) in high-risk twin pregnancies.
Measured: 6-7 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start20 Jan 2023
- Primary completion24 Aug 2024
- Study completion14 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy With Antenatal ProblemStudies of the same condition, open and under way.
- More trials run by Benha 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adel Farag Al Kholy, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319715
- Sponsor's protocol ID
- Rc 4.12.2022
- Status last verified
- Dec 2025
- First submitted
- 20 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cervical Cerclage and Vaginal Progesterone May Readjust the Deregulated Cervicovaginal Fluid Inflammatory Milieu and Improve Outcomes of Twin Pregnant Women
- ClinicalTrials.gov ID
- NCT07319715
- Acronym / sponsor ID
- Rc 4.12.2022
- Conditions
- Twin Pregnancy With Antenatal Problem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 14 Jun 2025 (actual)
- First posted
- 6 Jan 2026 (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.
Twin pregnancies face a high risk of complications, most notably preterm birth (delivery before 37 weeks), which is a major cause of infant death and illness globally. For women carrying twins who are identified as having a short cervical length (cervix measuring 25 millimeters or less), there is currently no single, highly effective preventative treatment. This study is a randomized clinical trial designed to determine if a combined therapy of Cervical Cerclage (a surgical stitch to support the cervix) and Vaginal Progesterone (a hormone medication) is more effective than standard care in preventing preterm birth and improving the overall health outcomes for both the mother and the babies. The trial will also investigate the biological basis of this effect by measuring specific inflammation markers (cytokines like Interleukin-1$\beta$, 6, 8, and Tumor Necrosis Factor-α) in the cervical fluid before and after the intervention, to see if the combined treatment helps to reduce harmful local inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervical Cerclage (CC) | Active comparator | Procedure: McDonald Cervical CerclageParticipants in this arm undergo a McDonald cerclage technique. This involves placing a purse-string suture (No. 1 or 2 braided or monofilament) around the cervix to close the internal os. The suture is typically removed at 37 weeks of gestation. |
| Vaginal Progesterone Therapy (VPT) | Active comparator | Drug: Vaginal Progesterone Therapy (VPT)Participants receive 100 mg vaginal progesterone inserts (e.g., Endometrin) administered twice daily. This treatment continues until spontaneous labor occurs or until the 37th week of pregnancy. |
| Combined Therapy (CC/VPT) | Active comparator | Procedure: McDonald Cervical Cerclage, Drug: Vaginal Progesterone Therapy (VPT)Participants receive both the surgical Cervical Cerclage procedure and the daily Vaginal Progesterone inserts as described in the individual arms above. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type of Pregnancy: Women with confirmed twin pregnancy (TP).
- Cervical Length: Short cervical length (CL) defined as ≤25 mm.
- Timing of Diagnosis: Short cervix detected via transvaginal ultrasound (TVU) at 11-13 weeks + 6 days, or detected during bi-weekly follow-up exams until 23 weeks + 6 days.
- Consent: Participants willing to undergo randomization and comply with the follow-up protocol.
Key exclusion criteria (4 listed)
- Multiple Gestation (High Order): Triplet or higher-order pregnancies.
- Fetal/Uterine Complications: Polyhydramnios, premature rupture of membranes (PPROM), or known uterine abnormalities.
- Acute Symptoms: Vaginal bleeding, fever, or signs of fetal distress.
- Maternal Comorbidities: Pre-existing or gestational hypertension, and diabetes mellitus.
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 |
|---|---|---|
| McDonald Cervical CerclageThe procedure involves exposing the cervix and grasping it with ring forceps. A purse-string suture using No. 1 or 2 braided or monofilament material is placed at the 12 o'clock position with a curved needle. The needle is inserted at the junction of the vaginal epithelium and the cervix, approximately 2 cm above the external os and distal to the vesicocervical reflection. After 5-6 cautious bites, the stitch is pulled tight to close the internal os. The suture is typically removed at 37 weeks of gestation, provided there is no labor or membrane rupture. | Procedure or surgery | Cervical Cerclage (CC), Combined Therapy (CC/VPT) |
| Vaginal Progesterone Therapy (VPT)Participants receive 100 mg vaginal progesterone inserts. Dosage \& Frequency: One 100 mg insert administered twice daily. Duration: The treatment continues until the onset of spontaneous labor or until the 37th week of pregnancy. | Drug | Combined Therapy (CC/VPT), Vaginal Progesterone Therapy (VPT) |
Primary outcome
Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration
Time frame: 6-7 Months
The proportion of patients who achieved a pregnancy duration of 37 weeks or more and/or significantly delayed delivery, reflecting the effectiveness of the administered treatment regimens (Cervical Cerclage, Vaginal Progesterone, or Combined Therapy) in high-risk twin pregnancies.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing McDonald Cervical Cerclage and Vaginal Progesterone Therapy (VPT) in people with Twin Pregnancy With Antenatal Problem, run by Benha 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 4 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: finished, as of the sponsor's last update on 6 Jan 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration (time frame: 6-7 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.