Intraumbilical Misoprostol in Retained Placenta

Hawler Medical University

Status and phase: Completed; Phase 1

Conditions: Retained Placenta

Treatments: Drug: Normal saline; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT01840813

HMU911

Details and patient eligibility

About

Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.

Full description

Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .

Enrollment: 46 patients

Sex: Female

Ages: 15 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women having singleton pregnancy
• 28 weeks of gestation or more delivered vaginally
• prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour

Exclusion criteria

• Who refused to participate in the trial
• Multiple pregnancies
• Previous Caesarean Section
• Haemodynamically unstable
• Severe anaemia (haemoglobin less than 8gm/dl)
• Chorioamnionitis

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups, including a placebo group

Misoprostol

Active Comparator group

Description:

4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein

Treatment:

Drug: Misoprostol

Normal saline

Placebo Comparator group

Description:

Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta

Treatment:

Drug: Normal saline