Antibiotic Prophylaxis in Ragged Placental Membranes

Study Overview
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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.

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.

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

Conditions
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Endometritis Postpartum, Endometritis, Membranes; Retained

Intervention / Treatment
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* Drug: Prophylactic antibiotics
* Other: No prophylaxis (Amox-clav withheld)


Participation Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prophylaxis<br>Current protocol of administering antibiotics maintained | Drug: Prophylactic antibiotics<br>* Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week<br>* Other names: Amox-clav given as per protocol;|
| Active Comparator: No prophylaxis<br>Antibiotics withheld, with appropriate observation and follow up | Other: No prophylaxis (Amox-clav withheld)<br>* 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<br>* Other names: Expectant management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postpartum endometritis | Postpartum endometritis is defined as follows, when presenting anytime within 6 weeks postpartum Fever (Axillary temperature > 37.5 degrees Celcius on 2 or more occasions at least 1 hour apart or temperature > 38 degrees Celcius on one occasion), occurring in the absence of apparent source of infection or alternative foci of infection. Increasing lochia loss or offensive lochia. Lower abdominal pain or suprapubic tenderness on palpation. The diagnosis is further supported by the following: Elevated total white cell count > 11.0 x 109 cells/L Positive genital swab culture. Incidence is calculated as follows: Number of patients diagnosed with endometritis in each arm/total number of patients allocated to each arm | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU admission rate | ICU admission as a result of endometritis. It is measured as follows: a. ICU admission rate in prophylactic antibiotic group= (Number of patients requiring ICU admissions and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis ) a. ICU admission rate in no prophylaxis group = (Number of patients requiring ICU admissions and NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis) | 6 weeks postpartum | 
| Rate of surgical evacuation of retained products of conception | Surgical procedure required as a result of ragged placental membrane or its complications. It is calculated as follows Surgical evacuation of retained products of conception in prophylaxis group= (Number of patients requiring surgical procedure and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis ) Surgical evacuation of retained products of conception in no prophylaxis group= (Number of patients requiring surgical procedure and NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis ) | 6 weeks postpartum | 
| Rate of Blood transfusion | Pack cell transfusion required as secondary to a complication from ragged placental membranes. This can be due to postpartum endometritis or surgical evacuation. It is calculated based on the number of patients requiring transfusion. The number of pack cells required per patient would be also be described. Blood transfusion in prophylaxis group= (Number of patients requiring pack cell transfusion and given antibiotic prophylaxis, regardless of duration/total number of patients given antibiotics prophylaxis ) Blood transfusion in no prophylaxis group= (Number of patients requiring pack cell transfusion and were NOT given antibiotic prophylaxis, regardless of duration/total number of patients NOT given antibiotics prophylaxis ) | 6 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes