Twin Pregnancy With Antenatal Problem
Conditions
Brief 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, 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.
Interventions
PROCEDUREMcDonald Cervical Cerclage
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.
DRUGVaginal 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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Treatment Regimens in Preventing Preterm Birth and/or Improving Pregnancy Duration | 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. |
Countries
Egypt
Outcome results
None listed