NCT03459599

Antibiotic Prophylaxis in Ragged Placental Membranes

Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 716 (actual)
• Sponsor: Sarawak General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In some centres, women are routinely given a course of antibiotics postnatally if ragged placental membranes were present at delivery. The investigators examined the necessity such an intervention.

Detailed description

Postpartum endometritis resulting in sepsis remain one of the leading cause of maternal mortality in developing countries. Ragged placental membrane is a risk factor for endometritis and is not infrequently encountered. Several hospitals in Malaysia, largely those geographically-removed currently practice administering prophylactic antibiotics for women with ragged placental membranes. The aim is to reduce the risk of postpartum endometritis in a subgroup of women who may present in dire straits. The investigators sought to examine the necessity of such protocols.

Conditions

• Endometritis Postpartum
• Endometritis
• Membranes; Retained

Interventions

Type	Name	Description
DRUG	Prophylactic antibiotics	Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week
OTHER	No prophylaxis (Amox-clav withheld)	Withholding Amox-clav, which is the current local practice for women with ragged placental membranes. This was replaced with appropriate counselling on signs and symptoms of endometritis, when and where women should present if the symptoms above occur. A follow up phone call was performed at 2 weeks and 6 weeks postpartum to ascertain well-being of patients

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-08-01
• First posted: 2018-03-09
• Last updated: 2018-03-12