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OpenTrials
Completed

NCT Number: NCT03430362

Effect Of Intravenous Hyoscine -N-Butyl Bromide In Management Of Prolonged Labor In Nulliparous

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy medical school

Cairo, 12151, Egypt

About this study

Women will be admitted when active phase of labour starts defined as the presence of at least three regular uterine contractions over 10 minutes with cervical dilatation four centimeters with cervical effacement not less than 50% and no progress of labor for 2 hours or more.

Amniotomy was done in those with intact membrane and continuous electronic fetal monitoring was done. Women with prolonged labor after these measures were randomly divided using automated web-based randomization system into 2 equal groups. Group I included 50 women received 40mg HBB (Buscopan, Memphis Co, Giza, Egypt) intravenous bolus injection. Group II included 50 women received 2 ml of normal saline. The obstetrician, participants and outcome assessor were all blinded to the group assignment. Labor will be monitored by Vaginal examination every two hours. The duration of the first stage was calculated from the time of cervical dilatation of three to four centimeters in active labor until a fully dilated cervix was observed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Nulliparous women.
  • cervical dilatation in the active phase of less than 1.2 cm/h for nulliparous women
  • Gestational age ≥ 37 weeks.
  • Singleton pregnancy.
  • Vertex presentation.
  • Cervical dilatation ≥ 4cm.
  • No evidence of maternal or fetal distress.
  • Average size baby.

Exclusion criteria

  • History of cervical surgery.
  • Mal-presentation and mal-positions.
  • Hypersensitivity to Hyoscine.
  • Contraindication for vaginal delivery.

Treatment and study plan

Hyoscine N Butylbromide

Drug
  • Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

Other names: Buscopan

normal saline 0.9%

Drug

Group B, will receive 2 ml of normal saline single intravenous dose

Other names: Saline

Primary outcomes

  1. the duration of active phase of first stage of labor

    Time frame: 8 hours after hyoscine adminstration

    time elapsed between start of active phase till full cervical dilatation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2018
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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