Induction of Labor in Pregnant Women With Prelabor Rupture of Membranes - Oxytocin or Misoprostol
Condition: Prelabor Rupture of Membranes
MeSH terms: Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of study is to compare the efficacy and safety of oral misoprostol versus oxytocin in
      induction of labor in pregnant women with prelabor rupture of membranes at term.
    

Detailed description: 
      Type of Study: Randomized controlled clinical trial. Study Setting: The study will be
      conducted at Ain Shams University Maternity Hospital (ASUMH) at labor ward.

      Study Population: pregnant women attending at Ain Shams University Maternity Hospital for
      induction of labor at term

      Sample Size: The study will be conducted on (170) women; they will be subdivided into 2
      groups.

        -  1st group (misoprostol group): induction of labor by 25µg misoprostol oral tablet every
           4 hours with maximum200 µg.

        -  2nd group (oxytocin group:control group): induction of labor done by administration of
           oxytocin infusion according to ASUMH local protocol.

        -  Sample size Justification: Using PASS 11program for sample size calculation and
           according to (Zeteroğlu S et al, 2006), the expected mean interval from induction to
           delivery in misoprostol group=10.61 ± 2.45 hours and oxytocin group=11.57 ± 1.91 hours.
           Sample size of 85 women per group can detect the difference between two group with
           power80% setting alpha error at 0.05.

      Study procedures and interventions:

        1. After approval of study protocol; pregnant women attending Ain Shams University
           Maternity Hospital for induction of labor will be enrolled into the study according to
           inclusion and exclusion criteria.

        2. History taking, examination and investigation will be done to choose eligible patients.

           History: personal, obstetric history, past history (any medical or surgical disorder)

           Examination:

           General: pulse, blood pressure, temperature. Abdominal: size of the uterus, previous
           scar, presentation Per vaginal examination (PV): assessment of Bishop Score.
           Investigations: Routine laboratory: (CBC, Urine analysis, blood group and Rh typing) and
           ultrasound for (viability of fetus, fetal biometry and estimated fetal weight, amniotic
           fluid, placental localization), admission fetal heart rate (FHR) assessment (non-stress
           test "NST")

        3. Eligible patients will be randomized using a computer-generated sequence 1:1 either to
           the misoprostol group or to oxytocin group.

      The supervisor will do all procedures. Randomization: Will be done using computer generated
      randomization sheet using Med calc. ©.

      Allocation and concealment: will be done using sealed opaque envelopes. Each woman will be
      invited to pull out an envelope, and according to the letter within she will be allocated to
      either group (group A: oral misoprostol; group B: oxytocin group) 4. Intervention:

        1. st group (Misoprostol group): induction of labor by 25µg misoprostol oral tablet every 4
           hours maximum200 µg.( Alfirevic Z et al., 2014)

        2. nd group (Oxytocin group): oxytocin infusion according to ASUMH oxytocin protocol.

      Syntocinon Mix: {if patient fit for induction} Put 3 international units "IU" oxytocin
      (3000mIU) +50ml of normal saline in syringe pump= (60mIU/ml).

      Commence at 1ml/hour (1mIU/min) for 1/2 hour.

        -  If contractions inadequate +fetal monitor healthy 2 ml/hour for 1/2 hour.

        -  If contractions inadequate +fetal monitor healthy 4 ml/hour for 1/2 hour.

        -  If contractions inadequate +fetal monitor healthy 6 ml/hour for 1/2 hour.

        -  If contractions inadequate +fetal monitor healthy increase by 2ml/hr. for max.
           27ml/hour.

      At any point there's fetal or maternal distress (e.g. pathological FHR pattern, antepartum
      hemorrhage, etc.) the study intervention will be stopped, and the maternal/fetal condition
      will be managed by cesarean section.

      5. Follow up: Continuous electronic fetal heart rate monitoring Maternal: vital data, uterine
      contractions, cervical changes (PV/4hours). Time to active phase (cervical dilatation: 6cm)
      will be noted, and then follow-up monitoring till delivery.

      6. End point: Reaching maximum dose of drugs with failure of induction of labor in which
      another decision should be taken. Also, at any point there's fetal or maternal distress (e.g.
      pathological FHR pattern, antepartum hemorrhage, etc.) the study intervention will be
      stopped, and the maternal/fetal condition will be managed accordingly.

      7. Data collection and recording case record form: The data will be collected in a case
      report form (age, parity, gestational age, blood pressure, bishop score on admission, time
      till active phase, induction to delivery interval, any side effects if present, mode of
      delivery, birth weight, neonatal intensive care unit (NICU) admission, Apgar score, hospital
      stay, maternal intensive care unit (ICU) admission.

      Statistical analysis:

      The collected data will be revised, coded, tabulated and introduced to a personal computer
      (PC) using Statistical package for Social Science (SPSS 20.0.1 for windows; SPSS Inc,
      Chicago, 2001). Quantitative variables will be expressed as mean and standard deviation (SD),
      or median and interquartile range (IQR) according to type of data. Qualitative variables are
      expressed as frequencies and percentages. Student t test and Mann Whitney test will be used
      to compare a continuous variable between two study groups. Chi square test will be used to
      examine the relationship between categorical variables. A P-value< 0.05 will be considered
      statistically significant.

      Ethical and Safety Consideration:

      This study will be done after approval of the ethical committee ,faculty of Medicine, Ain
      Shams University. Informed consent will be taken from all participants before recruitment in
      the study, and after explaining the purpose and procedures of the study. The investigator
      will obtain the written, signed informed consent of each subject prior to performing any
      study specific procedures on the subject. All data will be collected confidentially. At any
      point there's fetal or maternal distress (e.g. pathological FHR pattern, antepartum
      hemorrhage, etc.) the study intervention will be stopped, and the maternal/fetal condition
      will be managed accordingly.
    

Intervention name(s): Misoprostol; Syntocinon
Intervention type(s): Drug; Drug
Intervention description(s): a synthetic prostaglandin E1 analogue; synthetic oxytocin
Other intervention name(s): vagiprost; oxytocin
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1st group (misoprostol group): induction of labor by 25µg misoprostol oral tablet every 4 hours with maximum200 µg.
2nd group (oxytocin group:control group): induction of labor done by administration of oxytocin infusion according to ASUMH local protocol.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oxytocin; misoprostol