Carbetocin Versus Oral Tranexamic Acid Plus, Buccal Misoprostol on Blood Loss After Vaginal Delivery
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Excessive bleeding at or after childbirth accounts for about half of all the post-partum
      maternal deaths in developing countries and is the single most important cause of maternal
      mortality worldwide. Post-partum hemorrhage (PPH) is the major contributor to maternal
      mortality worldwide representing at least 25% of the maternal deaths annually. Prevention of
      PPH has become a global aim to reduce maternal mortality. Uterine atony is the main cause of
      PPH; therefore, active management of the third stage of labor has emerged as a most actual
      tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH
      occur within 4 hours of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that
      blocks the lysine-binding site of plasminogen to fibrin. Misoprostol is effective when given
      orally, buccal, sublingually, vaginally, or rectally, so it might be used by traditional
      birth attendants, or self-administered, in cases of home-births occurred without the
      attendance of health personnel or where women are at most risk for occurrence of severe PPH.
      So, the current study aims to evaluate the effect of prophylactic oral TA plus buccal
      misoprostol in the prevention of primary PPH after routine active management of the third
      stage of labor in women at low risk for uterine atony in comparison with carbetocin and
      buccal misoprostol alone.
    

Detailed description: 
      All women admitted to the reception unit for vaginal delivery were invited to participate in
      the study. The investigators included women aged (20-35 years) with a singleton pregnancy in
      a cephalic presentation between 38 and 42 weeks gestation. The participated women have
      entered the screening phase of the study. This phase included history taking (age, parity,
      and gestational age) with measurement of weight, temperature, and initial hemoglobin level.
      The investigators excluded women with medical disorders such as cardiac, hepatic, renal,
      neurologic disorders thromboembolic disease, blood disorders, diabetes, gestational
      hypertension, and pre-eclampsia. Women at risk for PPH as grand multipara (parity >5),
      multiple pregnancies, polyhydramnios, fetal macrosomia, antepartum hemorrhage, prolonged, and
      obstructed labor were also excluded. Moreover, we excluded women with a scarred uterus or
      previous instrumental delivery and those suffering from hypersensitivity to TA. women were
      allocated to one of the three study groups: group I (carbetocin group) received 100 mc
      carbetocin IV after delivery of the baby, group II (misoprostol group) received 600 mg buccal
      misoprostol after delivery of the baby, and group III (TA plus misoprostol group) received
      1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after
      delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min
      after which any remnants are swallowed.
    

Intervention name(s): carbetocin; Tranexamic acid plus misoprostol; misoprostol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute; 1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.; 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
Other intervention name(s): Active Comparator; active comparator; active comparator
Intervention MeSH terms: Misoprostol; Tranexamic Acid; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: women were allocated to one of the three study groups: group I (carbetocin group) received 100 mc carbetocin IV after delivery of the baby, group II (misoprostol group) received 600 mg buccal misoprostol after delivery of the baby, and group III (TA plus misoprostol group) received 1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: carbetocin; tranexamic acid; postpartum hemorrhage; buccal misoprostol