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

Obstetric Labor Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04888871
• Other study ID #: 2020/123
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: May 2021
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 31, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Vacuum Extraction; Failure, Affecting Fetus or Newborn

Locations

Country	Name	City	State
Turkey	Zeynep Kamil Maternity and Childrens Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maternal morbidity		3 months