Antibiotic Prophylaxis in Ragged Placental Membranes

Sarawak General Hospital

Status: Completed

Conditions: Membranes; Retained; Endometritis; Endometritis Postpartum

Treatments: Drug: Prophylactic antibiotics; Other: No prophylaxis (Amox-clav withheld)

Study type: Interventional

Funder types: Other

Identifiers

NCT03459599

16-1016-31034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 716 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

1. 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.
2. 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
3. Prolonged rupture of membrane (>18 hours)
4. Retroviral disease, on long term oral or parenteral steroid or receiving other forms of immunosuppressants, including chemotherapy within the last one year.
5. Vaginal delivery for an intrauterine death
6. Penicillin allergy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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716 participants in 2 patient groups

Prophylaxis

Active Comparator group

Description:

Current protocol of administering antibiotics maintained

Treatment:

Drug: Prophylactic antibiotics

No prophylaxis

Active Comparator group

Description:

Antibiotics withheld, with appropriate observation and follow up

Treatment:

Other: No prophylaxis (Amox-clav withheld)