Trial | NCT03459599  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    716
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.
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.
Study Started
Oct 01
2016
Primary Completion
Mar 01
2017
Study Completion
Aug 01
2017
Last Update
Mar 12
2018

Drug Prophylactic antibiotics [amoxicillin, clavulanate (Augmentin)]

Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week

  • Other names: Amox-clav given as per protocol

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

  • Other names: Expectant management

Prophylaxis Active Comparator

Current protocol of administering antibiotics maintained

No prophylaxis Active Comparator

Antibiotics withheld, with appropriate observation and follow up

Criteria 

Inclusion Criteria:

All women who delivered vaginally beyond 24+0 weeks of gestation and were found to have ragged or retained placental membranes immediately after the third stage of labour were invited to participate in the study.

Exclusion Criteria:

Fever, within 5 days preceding delivery (Axillary temperature > 37.5oC on 2 or more occasions at least 1 hour apart or temperature > 38oC on one occasion). This also includes intrapartum fever.
Required oral or intravenous antibiotics for any other obstetric-related (ex. third or fourth degree tears, preterm prelabour rupture of membranes) or non- obstetric related (ex. pneumonia, acute pyelonephritis) reasons
Prolonged rupture of membrane (>18 hours)
Retroviral disease, on long term oral or parenteral steroid or receiving other forms of immunosuppressants, including chemotherapy within the last one year.
Vaginal delivery for an intrauterine death
Penicillin allergy
No Results Posted