The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial

Istanbul Bakirkoy Maternity and Children Diseases Hospital

Status and phase: Completed; Phase 4

Conditions: ıntrapartum Haemorrhage; Postpartum Haemorrhage

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01931410

Aşıcıoğlu-05

Details and patient eligibility

About

The investigators hypothesis in this study is that administration of rectal and sublingual misoprostol decreases intrapartum and postpartum haemorrhage.

Enrollment: 618 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. live and singleton pregnancy
2. Elective caesarean
3. Gestational week greater than 37 weeks
4. patient between 18-44 year old

Exclusion criteria

1. -multiple pregnancy
2. Preeclampsia
3. Gestational diabetes
4. Macrosomia
5. Oligohidraamnıos
6. Polihidraamnıos
7. Myoma
8. Morbid obesity
9. Coagulatıon defect (such as HELLP syndrome)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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618 participants in 3 patient groups, including a placebo group

sublingual

Placebo Comparator group

Description:

400 microgram mısoprostol will be administered sublıngually before elective caesarean

Treatment:

Drug: Misoprostol

rectal

Placebo Comparator group

Description:

rectal 600 mgr misoprostol will be administered

Treatment:

Drug: Misoprostol

synpitan

No Intervention group