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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyoscine group | Active Comparator | 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose |
|
| Control group | Placebo Comparator | Group B, will receive 2 ml of normal saline single intravenous dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyoscine N Butylbromide | Drug | 7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| the duration of active phase of first stage of labor | time elapsed between start of active phase till full cervical dilatation | 8 hours after hyoscine adminstration |
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Inclusion Criteria:
• Nulliparous women.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Maged | professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy medical school | Cairo | 12151 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33983512 | Derived | 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. |
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| ID | Term |
|---|---|
| D002086 | Butylscopolammonium Bromide |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D012602 | Scopolamine Derivatives |
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Group A will receive injection Hyoscine butyl bromide 20 mg first dose at the time of amniotomy, and second dose 2 hours after. Group B, will receive normal saline same volume first dose at the time of amniotomy, and second dose 2 hours after
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| Normal Saline 0.9% | Drug | Group B, will receive 2 ml of normal saline single intravenous dose |
|
|
| D014326 |
| Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |