Prediction of External Cephalic Version Success in Case of Breech Presentation At Term of Pregnancy: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- To evaluate ECV success rate.
研究概览
简要总结
This study aims to evaluate possible predictors for the successful od external cephalic version (ECV), a procedure that is indicated in your case due to breech presentation of your baby and your desire to avoid cesarean section. Before the procedure, a detailed ultrasound scan will be performed to measure several parameters. After the procedure we will collect data about the duration, outcome and eventual complications of ECV.
详细描述
Pregnant women with a diagnosis of fetal breech presentation, desirous of an attempt of ECV after counseling and written consent and hospitalized for the procedure will be consecutively enrolled. The following anonymous data will be recorded:
- Demographic and anthropometric data (i.e., age (y), ethnicity, height (m), weight (kg), BMI);
- Parity
- Gestational Age (weeks + days)
Before ECV attempt, the following evaluations will be performed:
-
Vaginal examination to evaluate the cervical dilatation and the level of presenting part (floating or not floating)
-
Fetal transvaginal ultrasound reporting:
-
biometry (BPD, HC, AC, FL, EFW);
-
Occiput position (right, left);
-
Back position (anterior, posterior, right, left);
-
Breech variant (footling, frank, complete);
-
Fetal leg posture (extended, flexed)
-
Placental localization;
-
Amniotic Fluid Index (AFI);
-
Fore-bag of amniotic fluid;
-
Eventual presence of nuchal cords;
-
Fetal head ballottement (yes, no);
-
Occiput-spine angle (see Figure 1)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 y.o.;
- •Pregnant women with a diagnosis of fetal breech presentation eligible and desirous for ECV;
- •Singleton;
- •At term (≥ 37 weeks);
- •Breech presentation;
- •No previous uterine scars or other indications for elective C-section;
- •Signed written informed consent to study participation.
排除标准
- •Age <18 y.o.;
- •Preterm gestational age;
- •Multiple pregnancies;
- •Indications for elective cesarean section;
- •Incomplete obstetrical data;
- •Refusal to provide informed consent.
- •Desire to an elective C-Section
- •Controindications for ECV or vaginal delivery (placental abruption, placenta previa, uterine malformations)
- •Reduction of amniotic fluid (AFI <4 cm)
- •Uterine contractions
- •Vaginal bleeding
- •Premature rupture of membranes
- •Nonreassuring fetal heart rate patterns before the procedure.
结局指标
主要结局
To evaluate ECV success rate.
时间窗: during the procedure
to evaluate clinical and ultrasound parameters possibly predictive of the success of ECV. This will allow the creation of a predictive model for adequate counseling for the women undergoing the procedure for the cephalic version of fetuses in breech presentation at term of pregnancy
次要结局
未报告次要终点
研究者
Carducci Brigida
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS