Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.

Sponsor

Ain Shams University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05206409

Collaborator

(none)

382

Enrollment

Location

10.2

Anticipated Duration (Months)

37.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the past years, numerous studies have been published on the use of ultrasound during labor, showing this is an effective, accurate and objective tool for the assessment of the fetal head position and station. Literature affirmed that traditional transvaginal digital examination is highly subjective and dependent on the operator's experience. On the contrary, the use of intrapartum suprapubic transabdominal ultrasound can improve accuracy in determination of fetal head position and the precise knowledge of the location of specific fetal head landmarks in relationship to maternal pelvis. Intrapartum ultrasound will assist obstetricians in the diagnosis of normal labor progression, suggesting when medical and or operative intervention should be taken in case of complications.

Condition or Disease	Intervention/Treatment	Phase
Prolonged Labor	Diagnostic Test: Ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

382 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Prediction of Delivery Mode by Ultrasound-assessed Fetal Position in Nulliparous Women With Prolonged First Stage of Labor.

Actual Study Start Date :

Jan 25, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Outcome Measures

Primary Outcome Measures

Mode of delivery [6 months]
Correlation between fetal head position and mode of delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

nulliparous women
Singleton pregnancy
prolonged first stage of Labor
average fetal weight
gestational age at or beyond 37 weeks

Exclusion Criteria:

IUFD
malpresentation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AinShams Maternity Hospital	Cairo		Egypt	002

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ain Shams University

ClinicalTrials.gov Identifier:

NCT05206409

Other Study ID Numbers:

MS 747/2021

First Posted:

Jan 25, 2022

Last Update Posted:

Feb 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 11, 2022