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Hyoscine and Hyoscine-Promethazine effects on the delivery

The effect of intramascular Hyoscine and Hyoscine-Promethazine on the duration of labour and deliveryoutcomes to nuliparous pregnant women(triple-blind randomize control trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT201512163027N29
Enrollment
213
Registered
2016-02-07
Start date
2015-12-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delivery. Single spontaneous delivery, unspecified

Interventions

Intervention 1: ( Ampul Hyoscine 20mg + 2cc distilled water) (total 3cc). Intervention 2: Ampul Hyoscine20mg(1cc) pluse Promethazine25mg(1cc) plus 1 cc distilled water (total 3cc). Intervention 3: di
Treatment - Drugs
Placebo
( Ampul Hyoscine 20mg + 2cc distilled water) (total 3cc)
Ampul Hyoscine20mg(1cc) pluse Promethazine25mg(1cc) plus 1 cc distilled water (total 3cc)
distilled water 3 cc

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 37-41 weeks for gestational age; begining uterus contraction spontaneus; 4-5 for dillatation; 50-60% for effasman; rupture aminiotic sac befor intervention but not more than 6h past from its rupture; one twin; nulliparous(with/without abortion in previeus pregnancy); lack of problem and sick in this pregnancy(for example preeclampsia, diabet,...); lack of controandication for normal delivery(HSV, CPD, placenta previa,... ); lack of problem in fetuse(unormal presentation); normal BMI in this pregnancy; fetus weight in normal range(2500-4000) according sonography or clinical exam; lack of major hip tightness; cephalic presentation; major height at least 150cm; mather age(18-35) lack of glocome in mather(according to mathers statement); outgoing criteria(sensitivity to Hyoscine, unwillingness to continiue investigation, unormalfetus presentation, epidural analgisia)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Kind of vaginal delivery, rapture of delivery canal without episiatomy, cervical laceration and uterus atonia. Timepoint: since begining intervention to 2 hours after birth. Method of measurement: check list.;Total of first stage of delivery. Timepoint: since intervention to birth. Method of measurement: timer.;Tachycardia, bradycardia, lost of beat to beat variability and long time deseleration in FHR. Timepoint: Since intervention to birth. Method of measurement: use of CTG.

Secondary

MeasureTime frame
Total time for second and third stage of delivery. Timepoint: since camplet dilatation to delivery and exit plasenta. Method of measurement: timer.;1 and 5 appgars, need to revival, the severityof jaundice if admissed to NICU. Timepoint: since delivery to releasing mather. Method of measurement: check list.;Giddiness, dizziness, tachycardia, lips dryness,fulushing of face ,headache, nausea,. Timepoint: from intervention to 2 hours after delivery. Method of measurement: check list.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzane Shahmohammadi

Nursing and Midwifery Faculty

farzane.shah@yahoo.com+98 24 3422 2280

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026