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

• Conditions: Obstetric Labor Complications; Vacuum Extraction; Failure, Affecting Fetus or Newborn; Complicated Labour/Delivery Livebirth

• Registration Number: NCT04888871
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

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.

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2020-08-01
• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-14
• Last Update Submitted: 2021-05-14
• Study First Posted: 2021-05-17
• Last Update Posted: 2021-05-17
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
maternal morbidity	3 months

Trial Locations

Locations (1)

Zeynep Kamil Maternity and Childrens Hospital; 🇹🇷 Istanbul, Uskudar, Turkey