Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the proposed study is to examine the relationship between cerclage suture material of Ethibond and Prolene and its effect on the vaginal microbiome in a prospective randomized control trial. Ethibond is another commonly used suture material for performing cervical cerclage that shares some characteristics with previously studied suture materials. It is braided like the Mersilene, but thinner like the monofilament Prolene. The investigators will study whether Ethibond causes the vaginal microbiome to be adversely affected like Mersilene or whether there is a healthy microbiome like Prolene. This study will allow the investigators to determine whether it is advisable to continue to use Ethibond for cervical cerclage in clinical practice, or whether obstetricians should avoid its use as now done with Mersilene.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Braided Suture | Active Comparator | Patient in this group will have a cerclage with ethibond suture material |
|
| Non- Braided Suture | Active Comparator | Patient in this group will have a cerclage with prolene suture material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethibond Suture | Other | Cerclage placement with ethibond |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vaginal Microbiome | 16S rRNA gene sequencing will be performed | At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation) |
| Change in Vaginal Cytokine Expression | Cytokine analysis will be performed | At time of cerclage placement (11-14 wks gestation) and cerclage removal (35-36 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of preterm birth | The investigators will follow patients through their pregnancy and observe if suture material is related to increased preterm birth | Delivery between 24-26 weeks gestation |
Not provided
Inclusion Criteria:
dilation or cervical insufficiency
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meike Schuster, MD | Rutgers Robert Wood Johnson Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Maternal Fetal Medicine | New Brunswick | New Jersey | 08901 | United States | ||
| High Risk Obstetrics Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36464242 | Derived | Jayakumaran J, Angras K, Wang B, Paglia MJ, Rosen T, Schuster M. Monofilament vs multifilament suture for cervical cerclage: a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Feb;5(2):100823. doi: 10.1016/j.ajogmf.2022.100823. Epub 2022 Dec 2. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002581 | Uterine Cervical Incompetence |
| ID | Term |
|---|---|
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Prolene Suture |
| Other |
Cerclage placement with prolene |
|
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D000091662 | Genital Diseases |