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

• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04888871
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 15.9
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obstetric Labor Complications; Vacuum Extraction; Failure, Affecting Fetus or Newborn; Complicated Labour/Delivery Livebirth

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 Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Randomized Control Trial for Comparison of Prevention and Appropiate Obstetric Interventions for Prolonged Second Stage Labor at Term Pregnancies During Vaginal Delivery
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: May 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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
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
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

Outcome Measures

Primary Outcome Measures

1. maternal morbidity [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zeynep Kamil Maternity and Childrens Hospital	Istanbul	Uskudar	Turkey	34660

Sponsors and Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Resul Karakuş, Specialist, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• ClinicalTrials.gov Identifier: NCT04888871
• Other Study ID Numbers: 2020/123
• First Posted: May 17, 2021
• Last Update Posted: May 17, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Resul Karakuş, Specialist, Zeynep Kamil Maternity and Pediatric Research and Training Hospital: labor stage, second
• Additional relevant MeSH terms: Obstetric Labor Complications

Study Results

No Results Posted as of May 17, 2021