Pregnancy Complications
Conditions
Brief summary
External Cephalic Version (ECV) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. Its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ECV is an effective technique to reduce the rate of cesarean sections and is recommended by the Spanish Society of Obstetrics and Gynecology (SEGO) and the World Health Organization (WHO) Cesarean Section Working Group. The WHO aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections. Despite Propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ECV, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. The Obstetric Anesthesiology Section of the Spanish Society of Anesthesiology and Resuscitation recommends the use of locoregional analgesia in ECV.
Detailed description
This project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ECV. Therefore, the objectives of this study are: * To compare the effect of sedation with Propofol on the success rate of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the rate of complications of ECV compared to spinal analgesia. * To compare the effect of sedation with Propofol on the length of hospital stay of ECV compared to spinal analgesia. Locoregional analgesia requires a longer hospital stay than sedation with Propofol and may mask an early diagnosis of complications after ECV, such as placental abruption, which is identified in the initial stages by intense abdominal pain.
Interventions
Sedation with propofol
DRUGSpinal analgesia with bupivacaine
Spinal analgesia with bupivacaine
Sponsors
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An open randomized clinical trial has been designed comparing sedation with propofol versus spinal analgesia.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Voluntary participation. * Older than 18 years. * Non-cephalic presentation. * Desire to attempt a vaginal birth. * Normal blood count and coagulation prior to the intervention
Exclusion criteria
* Age under 18 years old. * Multiple gestation. * Cephalic presentation. * Risk of fetal compromise. * Unexplained active bleeding. * Absolute contraindication for vaginal delivery (Placenta Previa) * 2 or more previous cesarean sections. * Previous myomectomy with entry into the uterine cavity * Maternal fever. * Thrombocytopenia (\<85,000 platelets). * Maternal spinal anomaly. * Intolerance or allergy to Propofol or any of its components. * Intolerance or allergy to bupivacaine or any of its components. * Contraindication for intrathecal sedation or analgesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the success rate of external cephalic version | Up to 24 months. | Number of external cephalic version when Propofol is used as a sedative agent or spinal analgesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of emergency cesarean sections in the first 24 hours after the procedure when using Propofol as a sedative agent or spinal analgesia in ECV. | Up to 24 months | Number of emergency cesarean |
| postprocedural pain when Propofol is used as a sedative agent or spinal analgesia in ECV | Up to 24 months | Visual Analogue Scale (VAS) pain consists of 9 items on which participants rate their perceived dizziness on a scale between 1 (no dizziness) and 10 (most dizziness) in different visual vertigo-inducing environments |
| rate of clinically relevant hypotension (SBP <90 mmHg or a 20% decrease from baseline SBP) when using Propofol as a sedative agent or spinal analgesia in ECV | Up to 24 months | number of episodes of hypotension hypotension |
| ECV (external cephalic version) complication rate when using Propofol as a sedative agent or spinal analgesia. | Up to 24 months. | Number of complications |
| angle of progression of fetal presentation as a predictor of ECV success. | Up to 24 months | angle of progression of fetal presentation |
| angle of progression of fetal presentation as a predictor of complications of ECV. | Up to 24 months | angle of progression of fetal presentation as a predictor of complications of ECV. |
| degree of tissue oxygenation of the placenta during ECV by analyzing a pilot sample with infrared spectroscopy (NIRS) | Up to 24 months | degree of tissue oxygenation |
| rate of nausea or vomiting when using Propofol as a sedative agent or spinal analgesia in ECV. | Up to 24 months | Level of nausea or vomiting in clinical history |
Countries
Spain
Contacts
Primary ContactJavier Sanchez Romero, MD
Backup ContactCatalina De Paco Matallana, MD
Outcome results
None listed