NCT03742531

Brief Summary

This study evaluates the need of oxytocin therapy in active phase of labor. there will be two groups treating with oxytocin in latent phase.One group will be treated with low dose oxytocin therapy and the other group will be treated with high dose oxytocin therapy. oxytocin treatment will be ceased at the beginning of the active phase of labor. the need of oxytocin treatment in active phase of labor will be compared between two groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

March 25, 2018

Last Update Submit

January 18, 2021

Conditions

OxytocinInduction of Labor

Outcome Measures

Primary Outcomes (1)

  • need for oxytocin retreatment

    need for oxytocin retreatment due to inadequate uterine contractions and labor arrest

    an average of one year

Secondary Outcomes (4)

  • length of active phase

    an average of one year

  • ratio of caesarean section

    an average of one year

  • total oxytocin dose

    an average of one year

  • APGAR scores

    an average of one year

Study Arms (2)

low dose group

ACTIVE COMPARATOR

oxytocin therapy starting with 2mU/min increased by 2 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.

Drug: oxytocin

high dose group

ACTIVE COMPARATOR

oxytocin therapy starting with 4mU/min increased by 4 mU/min every 15 minutes. oxytocin will be stopped at the beginning of the active phase of labor.

Drug: oxytocin

Interventions

oxytocinDRUG

one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.

Also known as: synpitan
high dose grouplow dose group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsterm pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Live fetus in cephalic presentation, sonographically estimated fetal weight less than 4200 g, undergoing induction of labor at 37-42 weeks of gestation, having indications of labor, no previous uterine surgery

You may not qualify if:

  • malpresentation, placenta previa, previous uterine surgery, multiple gestation, active genital herpes, non-reassuring fetal heart rate pattern

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zeynep Kamil Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • ahmet eser

    Zeynep Kamil Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 25, 2018

First Posted

November 15, 2018

Study Start

December 15, 2018

Primary Completion

June 15, 2019

Study Completion

December 1, 2019

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

TU(1)