ClinicalTrials.gg
Status unknownNCT02557087Updated Sep 23, 2015

Hyoscine ButylBromide for Intrapartum Analgesia

A Phase 2 interventional study of Hyoscine and Pethidine in Analgesia, Obstetrical, sponsored by Ain Shams Maternity Hospital. Status unknown. Open to female participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by Ain Shams Maternity Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
20 Years to 30 Years
Sex
Female
01

Study summary

The aim of this study is to assess whether hyoscine butylbromide is as effective as pethidine for analgesia during the first stage of labor.

02

Conditions studied

  • Analgesia, Obstetrical

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03

In context

Agnosia

1,269 studies on the registry are indexed under Agnosia; 524 are open to participants now.

This study's planned enrollment of 104 is above the median of 75 across 1,089 interventional studies indexed under Agnosia.

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Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primiparity
  • Active phase of labor (cervical dilatation of 3-5 cm, in the presence of adequate uterine contractions; lasting at least 40 seconds at intervals of 3-4 minutes)
  • Maternal age between 20-30 years
  • Singleton term pregnancy (37-42 weeks of gestation)
  • Vertex-presenting fetus

Exclusion criteria

Exclusion Criteria:

  • Clinical evidence of cephalopelvic disproportion.
  • Scarred uterus; previous cesarean section, hysterotomy or myomectomy.
  • Any medical disorders associated with pregnancy.
  • Fetal distress
  • Receiving any regional or parenteral analgesia before recruitment in the study
  • Known hypersensitivity to the drug family
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Hyoscine

    Intravenous administration of Hyoscine N-butylbromide diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

    Drug: Hyoscine

  • Active comparator
    Pethidine

    Slow intravenous administration of pethidine, 50 mg to be diluted in 10 mL of sterile water (single dose), as an analgesic during the first stage of labor, given by a member of the study team.

    Drug: Pethidine

Interventions

06

What researchers measure

Primary outcomes

  1. The efficacy of intravenous tenoxicam to supply adequate analgesia as indicated by changes in the pain intensity score using the visual analog scale.

    Assessment is to be done and followed up by the investigator at ½, 1, 2, 3 and 4 hours from drug administration. Scores range from 0 \[no pain\] to 10 \[worst possible pain\].

    Time frame: 4 hours

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2015
First posted
Sep 23, 2015
Start
Sep 2015
Primary completionEst.
Mar 2016
CompletionEst.
Mar 2016
Last update
Sep 23, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02557087
Responsible party
Hamdy Bakry Mohye Soliman El Kinawy (TA, Ain Shams Maternity Hospital) — Principal investigator
First posted
Sep 23, 2015
Start date
Sep 2015
Primary completion
Mar 2016 (estimated)
Completion
Mar 2016 (estimated)
Last update
Sep 23, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Scopolamine

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