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ID
Source
Brief title
Health condition
Trial of labor after previous cesarean delivery
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of successful TOL will be the primary outcome measure in this study.
Secondary outcome
Secondary outcome measures will be reason for secondary CD, percentage instrumental vaginal deliveries, oxytocin augmentation, complications during delivery (e.g. uterine ruptures), maternal blood loss, duration of first and second phase of labor, neonatal outcomes such as Apgar score <7 after 5 minutes, neonatal metabolic acidosis defined as pHa<7.05 and BD>12, admission to neonatal intensive care unit and perinatal mortality.
Background summary
We hypothesize that electrohysterography (EHG) will help to increase the rate of successful trial of labor after cesarean derlivery. Patients will be randomized to either uterine monitoring using tocodynamometry or electrohysterography during a trial of labor after previous cesarean delivery.
Study objective
We hypothesize that the percentage of successful TOL will increase with the use of EHG because EHG provides more accurate assessment of UA, allowing for better optimization of the contraction pattern during labor. Besides, more reliable monitoring will make doctors and patients feel safer during a TOL and therefore making a successful TOL more likely. We also hypothesize that EHG is more capable of detecting an uterine rupture in early stage than TOCO. EHG can show subtle changes in baseline, whereas for TOCO the baseline is not reliable at all.
Study design
First inclusion 22-11-2017
Intervention
Electrohysterography as method of monitoring uterine activity during a trial of labor after previous cesarean delivery
Inclusion criteria
- Pregnant women aged 18 years or older with previous CD
- Singleton pregnancy
- 37 to 41 weeks of gestation
- Cephalic presentation
- Spontaneous onset of labor
All patients included for this study must provide informed consent.
Exclusion criteria
- Estimated fetal weight >4000g
- Maternal age above 40 years
- Classical vertical or T- or J-incision of uterus
- Previous uterine rupture
- Cesarean delivery in previous 12 months
- Labor dystocia or failed induction as indication for previous cesarean delivery
- Placenta praevia, vasa praevia, fetus with relevant congenital malformation that can influence the delivery mode
- Primary infection of genital herpes simplex or active HIV
- Suspicion for abruptio placentae
- Dermatologic diseases, external or internal electrical stimulator and water birth.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8199 |
| Other | Ethical approval committee of Maternal and Child Hospital of Shijiazhunag (China) : 20171018 |