Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the
      uterine wall (hysterotomy). This definition does not include removal of the fetus from the
      abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy
    

Detailed description: 
      patients and methods:

      Type of Study

      A prospective registered, double blinded, randomized controlled trial

      Settings and localizations:

      Operative list and emergency unit at Obstetrics and Gynecology Department, Women Health
      Hospital, Assiut university, Egypt

      Preliminary assessment of the patient

      Obtain a detailed history from the patient

        -  Examination of the patient

             1. General examination and evaluation of the vital signs ofthe patient ( pulse , blood
                pressure , temperature and respiratory rate)

             2. Obstetrical examination

                Ultrasonograghic assessment (fetal viability , number of gestation, placental
                location, amniotic fluid index)

                Investigations ( complete blood count, Prothrombin time and concentration).

                Inclusion criteria:

                All legally adult pregnant women , above 18 years old ,at term with singleton
                pregnancies booked for elective caesarean section accepting to participate in the
                study.

                Indications of cesarean section:

                Repeated caesarean section(previous 2 cs or more).

                previous one caesarean with oligohydramnios.

                previous one caesarean with contracted pelvis.

                previous one caesarean with malpresentation.

                previous one caesarean section with decreased fetal movement.

                primigravida with malpresentation.

                primigravida with contracted pelvis.

                Exclusion criteria:

                Medical disorders involving the heart,liver,kidney or brain.

                Diabetes mellitus and hypertension.

                Patients requiring blood transfusion due to anemia.

                Risk factors for uterine atony e.g. macrosomia , polyhydramnios ,multiple
                pregnancies.

                Placenta previa or placental abruption.

                Previous major obstetric haemorrhage (>1000ml in previous Deliveries).

                Known fibroid or adenomyosis.

                Severe preeclampsia.

                Uterine anomalies.

                Women who received anticoagulant therapy.

                Blood disorders (e.g. coagulopathies , thrombocytopenia).

                Consent

                Verbal and written consent were obtained from all eligible women .

                The candidate women were divided into two groups. A computer generated random
                numerical table was used by an independent statistician to prepare sealed opaque
                envelopes containing a group assignment. Two groups of envelopes, corresponding to
                two study groups, were given to a third party (a nurse), who was unaware of the
                contents. The nurse distributed envelopes to patients, alternating between the
                groups. Patientsassigned to group 1 received 5 IU oxytocin IV after delivery of the
                fetus+ 2 tabs placepo . Patients assigned to group 2 received 400 in the buccal
                space after anaesthesia + Iv saline infusion

                Procedure:

                Cesarean deliveries were performed by well- trained resident doctor supervised by
                Assistant lecturer or Obstetrician consultant.

                Cesarean section was performed under spinal anesthesia. Novasoconstrictor was used
                unless the blood pressure dropped by 20% fromthe baseline value; if this was the
                case, 10 mg ephedrine was given.

                Cesarean Delivery technique was the same in all recruited women.

                Abdominal skin incision was done through a Pfannenstiel incision 2 to 3cm above the
                symphysis pubis, with the mid portion of the incision within the shaved area of the
                pubic hair for a length of about 10-12cm was done. After the rectus fascia was
                opened, the rectus

                muscles were separated and dissected off the peritoneum which was

                picked up between two tissue forceps and opened longitudinally. The visceral
                peritoneum was dissected sharply and gently to separate the bladder from the
                uterus. The

                uterus was opened through a transverse lower segment incision.

                After clamping of the umbilical cord, the women received 1.5 gm Ampicillin
                -Sulbactam (Ultracillin, Sedico, Egypt) and 80 mg garamycin (Epigent, EPICO, EGYPT)

                Uterine repair by absorbable continuous vicryl 1 sutures in two layers , parietal
                peritoneum was sutured by absorbable continuous vicryl sutures, rectus sheath was
                closed by absorbable continuous vicryl 1.

                subcutaneous fatty layer was closed by absorbable continuous vicryl 0sutures, skin
                was closed by vicryl 2-0 by subcuticular sutures.

                All the towels were weighed before and after cesarean section and the difference
                were calculated, the amount of intraoperative blood loss was estimated in the
                suction apparatus in ml. A trained nurse was responsible for blood and amniotic
                fluid collection during surgery using two separate suction sets, as well as for
                weighing the surgical towels before and after surgery; all towels that were used
                were of the same size and weight and every 1 gm increase in weight was equated with
                1-mLblood loss. The total amount of intra-operative blood loss was
                calculated.(blood loss in suction apparatus plus weight difference of used towels

                Second trained nurse was responsible for post-operative external blood loss
                measurement during the first 24 hours after surgery by weighing the soaked towels
                placed in the vulvar area. The post-operative blood loss was calculated (weight
                difference of towels placed in the vulvar area .The overall blood loss was
                calculated. Another blood picture was obtained 24 hours postoperative to detect
                changes in Hb level. The same nurse was responsible for follow up body temperature
                2 hours after caesarean section (feverish if temperature is 38ºC or greater) and
                observation of the patient for nausea , vomiting , chills and diarrhea.

                Outcomes:

                Primary outcomes: involved estimation of intraoperative and

                postoperative blood loss for 24 hours ( blood loss estimation started immediately
                following the skin incision)

                Secondary outcomes:

                Changes in hemoglobin concentration ( hemoglobin concentrations were measured 2
                hours before surgery and 24 hours after surgery)

                Misoprostol-induced maternal adverse effects (postoperativenausea, vomiting,
                diarrhea, fever and chills .

                Need to use other uterotonic drugs (oxytocin or ergometrine).Need to do further
                surgical interventions ( uterine artery ligation ,hysterectomy or re-exploration of
                the patient)

                Need for blood transfusion.

                Sample Size:

                Sample size was calculated based on the primary outcome (the amount of
                intraoperative blood loss during cs ) based on the results of previous study ,the
                mean blood loss with the use of Iv oxytocinas588.9ml with a standerd deviation of
                96.3 ml (10).

                Assuming that buccal misoprostol is more effective in reducing blood loss by 10% 77
                participants in each group will have 95% power at significance to detect such a 5%
                difference

                women were include in each group taking in account a 10% 77 drop-out rate
                (Epi-info: centers for disease control and prevention

                Atlanta, GA)

                Approval of Ethical Considerations:

                The Research Ethics Committee of Faculty of Medicine, Assiut

                University approved the study protocol. Pregnant women who would

                undergo elective lower segment cesarean section at term ( ≥ 37 weeks)

                with normal fetal heart tracing received written and verbal information

                about the study and were asked to participate. Those who agreed signed

                an informed consent form

                Statistical Analysis:

                Data entry and analysis were carried out using Statistical Package

                of Social Sciences for windows (SPSS, Chicago, Illinois, USA) version 20

                Quantitative variables were presented in terms of mean± standard

                deviation and qualitative variables were expressed as frequency and

                percentage. Tests of significance (T-test and chi-square) were calculated

                Significance level was set at P value < 0.05.
    

Intervention name(s): Misoprostol; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): buccal tablets; intravenous drip
Intervention MeSH terms: Misoprostol; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention