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CompletedNCT03430362Updated Oct 7, 2021

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

An interventional study of Hyoscine N Butylbromide and Normal Saline 0.9% in Prolonged Labor, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-10-07.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Prolonged Labor
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • History of cervical surgery.
  • Mal-presentation and mal-positions.
  • Hypersensitivity to Hyoscine.
  • Contraindication for vaginal delivery.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    Hyoscine group

    7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

    Drug: Hyoscine N Butylbromide

  • Placebo comparator
    Control group

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

    Drug: Normal Saline 0.9%

Interventions

  • DrugHyoscine N Butylbromide

    7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose

    Also known as: Buscopan

  • DrugNormal Saline 0.9%

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

    Also known as: Saline

05

What researchers measure

Primary outcomes

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

    time elapsed between start of active phase till full cervical dilatation

    Time frame: 8 hours after hyoscine adminstration

06

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12151, Egypt
07

References and documents

Publications

  • Maged AM, Sorour EH, ElSadek MM, Hassan SM, Shoab AY. A randomized controlled study of the effect of hyoscine butylbromide on duration of labor in primigravida women with prolonged labor. Arch Gynecol Obstet. 2021 Dec;304(6):1513-1518. doi: 10.1007/s00404-021-06087-7. Epub 2021 May 13. PubMed 33983512 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03430362
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Feb 12, 2018
Start date
Mar 2, 2018
Primary completion
Dec 23, 2019
Completion
Feb 16, 2020
Last update
Oct 7, 2021

Study contacts

Ahmed Maged
principal investigator · professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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