Safety Study of Hyoscine N Butyl Bromide in Active Management of Labor
Condition: Labor Fast
Study type: Interventional
Phase: Phase 4

Summary: 
      Although Hyoscine N butyl bromide (HBB) is used liberally to facilitate cervical dilatation,
      there is little and inconclusive data about its efficacy. The aim of this study was to
      determine the efficacy and safety of HBB on the augmentation of labor.420 of total 1640
      pregnant women admitted to the investigators clinic (Sisli Ethal Training and Research
      Hospital, Obstetrics and Gynecology Department Obstetrics Service ) between 37-41 gestational
      weeks, active phase (cervical dilatation: 4 cm, cervical effacement: %50 or more) of
      spontaneous labor with vertex presentation enrolled to study. 382 of them were included in
      this study. Patients were randomized to receive intravenously(IV) either 20 mg/ml HBB or a
      similar amount of placebo (1 ml 0.9% NaCl) at the beginning of the active phase of labor. The
      medications applied as single dose. The time elapsed until the second stage of labor, second
      stage and third stage were measured.
    

Detailed description: 
      The investigators aimed to study the effects and safety of 20mg intravenous HBB for the
      shortening of labor in both prima- and multigravid women.The study designed as a double
      blind, randomized, controlled trial comparing the two groups of intervention; Intravenous 20
      mg (1mL) Hyoscine-N-Butylbromide (HBB) versus placebo (1mL saline) in both primigravid and
      multigravid women.Singleton, vertex presentation at term (gestational age range; 37-41weeks)
      primigravid and multigravid women without any chronic and pregnancy-induced diseases were
      included to the study. The investigators excluded the cases with premature rupture of
      membranes, preeclampsia, eclampsia, placental abruption, placenta previa, abnormal placental
      attachment, twin pregnancy, non- cephalic presentations, previous uterine surgery and
      cephalopelvic disproportion.Randomization was done by using cards .The women were allocated
      into two groups by using a sealed enveloped system.A yellow and a red card were placed
      separately in each sealed envelope. The syringes containing the drug and placebo were
      prepared by the investigational pharmacy staff and labeled with a yellow or red sticker on
      it. Each syringe contained either 1ml(20mg) of Hyoscine-N-Butylbromide (HBB) (MOLIT
      ampule,Adeko, Turkey) or 1 ml of normal saline solution (placebo) in which both of the
      liquids are colorless. The participants, nurses and doctors were all blinded to syringes. The
      patients were asked to pick up one envelope in order and the color of the card was
      corresponding to the sticker's color on the syringe.Nurses applied the selected color labeled
      syringe to each patient. Participants received the contents of the syringe as a single dose,
      given intravenously (IV).

      A partogram was drawn and vaginal examinations recorded in every 2 hours.The active phase of
      labor was defined as 4 cm cervical dilatation and 50% cervical effacement in the presence of
      regular uterine contractions (2-3 contractions in every 10 minutes). The drug was given only
      once when the active phase was achieved. Iatrogenic amniotomy was performed for women who did
      not have a spontaneous rupture of membrane at the time when the cervical ripening was 8 cm.
      The duration of labor during the first, second and third stages, oxytocin induction,
      iatrogenic amniotomy, pre- and postpartum haemoglobin levels, birth weight and APGAR scores
      were recorded. Neonatal APGAR scores were determined 1 and 5 minutes after birth.
    

Intervention name(s): hyoscine-N-butyl bromide(HBB); Saline
Intervention type(s): Drug; Drug
Intervention description(s): A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB) versus placebo ( a single dose of 20ml IV NaCl) on the active phase of labor; placebo ( a single dose of 20ml IV NaCl) versus A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB)on the active phase of labor
Other intervention name(s): Molit amp.; 0,9NaCl
Intervention MeSH terms: Scopolamine; Bromides; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cervix, active phase of labor, Hyoscine-N-Butylbromide (HBB)