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Clinical Trials/NCT04888871
NCT04888871
Unknown
Not Applicable

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery

Zeynep Kamil Maternity and Pediatric Research and Training Hospital1 site in 1 country150 target enrollmentFebruary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstetric Labor Complications
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Enrollment
150
Locations
1
Primary Endpoint
maternal morbidity
Last Updated
4 years ago

Overview

Brief Summary

Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery.

Detailed Description

This study includes prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42. Fetal head level will be at or below the ischial spines in all patients.Patients with fully dilated cervix will be included in the study and the bladder will be emptied completely on the labor table. Patients diagnosed with fetal distress will not be included in the study.Indicated patients will be randomly divided into three groups; one group will be only subjected to a Fundal Pressure (Kristaller Maneuver), second group will only be subjected to Vacuum Extraction and the third group will be subjected to both Fundal Pressure (Kristaller Maneuver) and Vacuum Extraction. Maternal episiotomy needs presence of second and third degree perineal tears, presence of postpartum hemorrhage and need for blood transfusion , cesarean rates and fetal first and fifth minute Apgar score , fetal blood gas parameters, presence of fetal trauma, need for neonatal intensive care will be evaluated among three randomized groups.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Responsible Party
Principal Investigator
Principal Investigator

Resul Karakuş

Specialist

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Eligibility Criteria

Inclusion Criteria

  • term pregnancy weeks between 37-42, singleton, vertex presentations
  • prolonged second stage of labor
  • Fetal head is minimum at the level of ischial spin
  • maternal incompatibility during/after second stage of labor
  • complete cervical dilatation

Exclusion Criteria

  • Fetal distress
  • Uncomplete cervical dilatation
  • twin pregnancies or polycyesia
  • Pregnancy weeks lower than 37weeks
  • other than vertex presentations
  • Fetal Anomalies

Outcomes

Primary Outcomes

maternal morbidity

Time Frame: 3 months

Study Sites (1)

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