NCT07208552

Brief Summary

The study population consists of term primigravida women undergoing induction of labor at a tertiary care referral center in Assiut, Egypt.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 28, 2025

Last Update Submit

September 28, 2025

Conditions

Keywords

Bishop Scoreprimigravida women

Outcome Measures

Primary Outcomes (1)

  • Rate of vaginal delivery

    The proportion of women achieving vaginal delivery after induction of labor within 24 hours of initiation.

    Within 24 hours

Study Arms (2)

Transvaginal Ultrasound Group (TVUS):

Participants undergo sonographic measurement of cervical length. A CL \<28 mm is considered favorable for successful induction. This method provides an objective and reproducible cervical assessment.

Bishop Score Group (BS):

Participants undergo digital vaginal examination to assign Bishop Scores. A score ≥6 is considered favorable for induction. This is the traditional method of assessing cervical readiness.

Eligibility Criteria

Sexall(Gender-based eligibility)
Gender Eligibility Detailsprimigravida women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants include 88 primigravida women at ≥37 weeks of gestation, each with a singleton pregnancy in cephalic presentation. All participants present with medical or obstetric indications for induction of labor, such as post-dates, oligohydramnios, mild preeclampsia, or premature rupture of membranes. Exclusion criteria include prior uterine surgery, multiple pregnancies, malpresentation, placenta previa, vasa previa, non-reassuring fetal status at admission, or maternal infections such as active genital herpes and HIV. A carefully designed sample size calculation ensures adequate power, with a final cohort of 44 women per study arm.

You may qualify if:

  • Singleton pregnancy
  • Cephalic fetal presentation
  • Gestational age ≥37 weeks (confirmed by reliable dating)
  • Indication for induction of labor (postdate pregnancy, oligohydramnios, mild preeclampsia, premature rupture of membranes)

You may not qualify if:

  • Previous uterine surgery (e.g., cesarean section, myomectomy)
  • Multiple gestation
  • Malpresentation
  • Placenta previa or vasa previa
  • Non-reassuring fetal heart status at admission
  • Active genital herpes or HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at the Obstetrics and Gynecology department

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

October 6, 2025

Record last verified: 2025-09