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临床试验/NCT02086994
NCT02086994已完成3 期

Carbetocin in Preventing Postpartum Bleeding in Women With Severe Preeclampsia.

khalid abd aziz mohamed1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol

研究概览

简要总结

We aim to compare carbetocin with misoprostol for the prevention of postpartum hemorrhage in patients with severe preeclampsia. The primary outcome is postpartum haemorrhage (blood loss of ≥ 500 ml) while our Secondary outcomes include use of additional uterotonics, need for blood transfusion, maternal adverse drug reaction, maternal complications and maternal death

详细描述

We conducted a prospective non-randomized study at Department of Obstetrics and Gynecology, Benha University Hospital, since March 2013 till June 2015, after approval of the study protocol by the Local Ethical Committee. A written informed consent was obtained from eligible women before induction or at early stage of labour.

Women with singleton pregnancies of more than 28 weeks' gestation who are admitted to hospital with severe preeclampsia and candidates for vaginal delivery were eligible for the study. Preeclampsia is labelled as severe in the presence of any of the following abnormalities.

  1. Persistent cerebral or visual disturbances or cerebral edema.
  2. Persistent epigastric pain with nausea or vomiting, or both.
  3. Systolic ≥160 mmHg or diastolic ≥110 mmHg on 2 occasions at least 6 h apart with the patient at bed rest.
  4. Proteinuria of ≥5 g on 24-hour urine collection. Urine dipsticks are not accurate for this purpose.
  5. Oliguria (˂500 mL in 24 hours).
  6. Pulmonary edema.
  7. Thrombocytopenia.

Our exclusion criteria are HELLP syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies. All patients were in stable condition (no evidence of maternal hemodynamic instability or fetal distress) and their management afterwards followed the standards accepted in our country and established guidelines for the management of hypertensive disorders of pregnancy. For hypertensive crisis the first drug used was hydralazine (5 mg IV every 15 minutes to a maximum total dose of 20 mg) and, if this was ineffective, Nifedipine (Epilat): 10 to 20 mg orally / 30 min (max 50 mg), Then 10-20 mg /4-6 h (max 120 mg/day) or labetalol (20 mg IV every 10 minutes to a maximum total dose of 300 mg). No patient needed additional treatment for their symptoms or developed antepartum complications that required admission to the intensive care unit. All patients were evaluated hourly and received magnesium sulphate to prevent eclampsia during the pregnancy and for a minimum of 24 hours postpartum.

The patients (60) were divided into two groups, Group A (30) received a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) while Group B (30) received misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with singleton pregnancies of more than 28 weeks' gestation who were admitted to hospital with severe preeclampsia and candidates for vaginal delivery were eligible for the study. Preeclampsia is labelled as severe in the presence of any of the following abnormalities:
  • Persistent cerebral or visual disturbances or cerebral edema.
  • Persistent epigastric pain with nausea or vomiting, or both.
  • Systolic ≥160 mmHg or diastolic ≥110 mmHg on 2 occasions at least 6 h apart with the patient at bed rest.
  • Proteinuria of ≥5 g on 24-hour urine collection. Urine dipsticks are not accurate for this purpose.
  • Oliguria (˂500 mL in 24 hours).
  • Pulmonary edema.
  • Thrombocytopenia.

排除标准

  • were HELLP syndrome, eclampsia, abruptio placentae, malpresentation, polyhydramnios, previous uterine scar, chorioamnionitis and multiple pregnancies

研究组 & 干预措施

cabetocin

Active Comparator

a single dose of carbetocin (100 μg in 1 mL ampoule, Pabal) given intravenously after delivery of anterior shoulder

干预措施: carbetocin (Drug)

misoprostol

Active Comparator

misoprostol (600 μg, 3 tables) sublingually after the delivery of the anterior shoulder of the baby.

干预措施: misoprostol (Drug)

结局指标

主要结局

Prevention of postpartum hemorrhage in patients with severe preeclampsia using carbetocin versus misoprostol

时间窗: 24 hours after delivery

prevention of postpartum haemorrhage

次要结局

  • measurement of blood loss during second stage of labour(24 hours after delivery)

研究者

发起方
khalid abd aziz mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

khalid abd aziz mohamed

lecturer

Benha University

研究点 (1)

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