Trials / Withdrawn
WithdrawnNCT03077633
Cerclage for Twins With Short Cervix
Cervical Cerclage for Twin Pregnancy With Sonographic Cervical Length 0.1 to 15.0 mm: A Randomized Clinical Trial
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Pediatrix · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A prospective randomized control trial that will compare cervical cerclage plus vaginal progesterone to vaginal progesterone along in twin pregnancies complicate by a short cervix (\</= 15.0mm) between 16w0d to 25w6d.
Detailed description
A prospective Randomized Trial that will test whether treatment with cervical cerclage plus vaginal progesterone improves pregnancy outcomes among women with twin pregnancy at 16 0/7 to 25 6/7 weeks of gestation who have a cervical length (CL) of 0.1 to 15.0 mm on transvaginal ultrasound exam, the rate of preterm birth at less than 32 weeks of gestation (PTB\<32 wks.) and the rate of adverse perinatal outcome will be lower in those treated with cervical cerclage plus vaginal progesterone than in those treated with vaginal progesterone alone.
Conditions
- Preterm Birth
- Preterm Labor With Preterm Delivery, Unspecified Trimester, Fetus 2
- Cervical Incompetence
- Cervical Shortening
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Cervical Cerclage placement | Cervical Cerclage placement |
| DRUG | Vaginal Progesterone | 200mg tab of vaginal progesterone administered daily from time of randomization until delivery. |
Timeline
- Start date
- 2017-10-01
- Primary completion
- 2018-01-17
- Completion
- 2018-01-17
- First posted
- 2017-03-13
- Last updated
- 2018-03-21
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03077633. Inclusion in this directory is not an endorsement.