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

NCT ID: NCT04888871

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2021-05-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Only Fundal Pressure (Kristeller Maneuver)

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Only Fundal Pressure (Kristeller Maneuver) and the postpartum evaluation of 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

No interventions assigned to this group

Only Vacuum Extraction

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying only vacuum extraction and the postpartum evaluation of 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

No interventions assigned to this group

Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction

prolonged second stage phase and not prolonged second phase in pregnant women to singletons at the weeks between 37-42, applying Both Fundal Pressure (Kristeller Maneuver) and Vacuum Extraction and the postpartum evaluation of 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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role: lead

Responsible Party

Resul Karakuş

Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zeynep Kamil Maternity and Childrens Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Resul Karakus, MD

Role: primary

resul-karakus@hotmail.com

+905059164216

Other Identifiers

2020/123

Identifier Type: -

Identifier Source: org_study_id