Cervical Sliding Sign to Predict Outcome of Induction of Labor

NCT06324279 | Active Not Recruiting DMC FDA Drug FDA Device

• 1 other identifier: 000017585
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the role of transvaginal ultrasound specifically a sign called cervical sliding sign, in the prediction of success of induction of labor. The prediction of outcome of induction of labor has always been an important topic to all obstetricians. Bishop score is traditionally considered reliable way to predict the outcome of induction of labor by assessing the cervical dilatation, effacement, position, and consistence and assessing the level of the fetal head in the birth canal. Since The bishop score remains a highly subjective method for prediction of outcome of induction of labor, the use of sonographic measurements such as cervical sliding sign can be a better predictor of successful induction of labor.The presence of CSS was defined as the sliding of the anterior cervical lip on the posterior one under gentle pressure of the transvaginal probe. Patients undergoing induction of labor with misoprostol will be checked for the cervical sliding sign. The mode of delivery, induction to active labor time and active labor to delivery time will be recorded and analysed to assess whether the sliding sign is an independent predictor of success of induction.

Conditions

Induction of Labor; Transvaginal Ultrasound: Cervical Sliding Sign

Outcome Measures

Primary Outcomes (3)

• Mode of delivery

  Vaginal or cesarean section

  48 hours

• Induction to active labor time

  Start of induction till cervical dilation of 6 cm

  48 hours

• Active labor to delivery time

  From cervical dilation of 6 cm till delivery of fetus

  10 hours

Study Arms (1)

term pregnant women with Singleton living fetus attending for induction of labor

Device: Transvaginal ultrasound; Drug: Misoprostol 200mcg Tab

Interventions

Transvaginal ultrasound DEVICE

Transvaginal ultrasound will be used to see the presence of cervical sliding sign

term pregnant women with Singleton living fetus attending for induction of labor

Misoprostol 200mcg Tab DRUG

Induction of labor by misoprostol

term pregnant women with Singleton living fetus attending for induction of labor

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on term pregnant women with Singleton living fetus attending Ain Shams University Maternity Hospital for induction of labor

You may qualify if:

• \. women age: from 18 to 45 years old.
• \. Single living term fetus with gestational age ≥ 37 weeks.
• Eligible for IOL. 4- Bishop score \<6 5- Estimated fetal weight \< 4Kg.

You may not qualify if:

• previous caesarean section. (increases risk of rupture uterus) 2- Multiple pregnancy, IUFD, preterm or macrosomic fetus (defined as fetus
• \>4.5kg or fetus of diabetic mother \>4Kg) (increases risk of shoulder dystocia) 3- Women with major uterine anomalies. (appendix A: ESHRE/ESGE classification for Female genital tract anomalies (Grimbizis GF, et al,. 2013) (increases risk of CS) 4- Vasa previa, placenta previa (increases risk of antepartum hemorrhage) 5- previous myomectomy reaching the endometrial cavity. (Increases risk of rupture uterus) 7- patient refuse to participate or inability to consent. (patient's right to refuse).

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Maternity hospital, ainshams university hospitals

Cairo, 11799, Egypt

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Omaima A Mahmoud, mbchb

  Ainshams university faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: September 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

EG (1)