Antibiotic Prophylaxis in Ragged Placental Membranes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-08-01

Brief Summary

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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.

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Detailed Description

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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

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Endometritis Postpartum Endometritis Membranes; Retained

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylaxis

Current protocol of administering antibiotics maintained

Group Type ACTIVE_COMPARATOR

Prophylactic antibiotics

Intervention Type DRUG

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

No prophylaxis

Antibiotics withheld, with appropriate observation and follow up

Group Type ACTIVE_COMPARATOR

No prophylaxis (Amox-clav withheld)

Intervention Type OTHER

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

Interventions

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Prophylactic antibiotics

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

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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Amox-clav given as per protocol Expectant management

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes