Antibiotic Prophylaxis in Ragged Placental Membranes

Not Applicable

Completed

• Conditions: Endometritis; Endometritis Postpartum; Membranes; Retained
• Interventions: Other: No prophylaxis (Amox-clav withheld); Drug: Prophylactic antibiotics

• Registration Number: NCT03459599
• Lead Sponsor: Sarawak General Hospital

Brief 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.

Study Timeline

• Study Start: 2016-10-01
• Primary Completion: 2017-03-01
• Study Completion: 2017-08-01
• Study First Submitted: 2018-02-23
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-02
• Last Update Submitted: 2018-03-08
• Study First Posted: 2018-03-09
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 716

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No prophylaxis	No prophylaxis (Amox-clav withheld)	Antibiotics withheld, with appropriate observation and follow up
Prophylaxis	Prophylactic antibiotics	Current protocol of administering antibiotics maintained

Primary Outcome Measures

Name	Time	Method
Incidence of postpartum endometritis	6 weeks postpartum	Postpartum endometritis is defined as follows, when presenting anytime within 6 weeks postpartum; 1. 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.; 2. Increasing lochia loss or offensive lochia.; 3. Lower abdominal pain or suprapubic tenderness on palpation.; The diagnosis is further supported by the following: 1. Elevated total white cell count \> 11.0 x 109 cells/L; 2. 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

Secondary Outcome Measures

Name	Time	Method
Rate of surgical evacuation of retained products of conception	6 weeks postpartum	Surgical procedure required as a result of ragged placental membrane or its complications. It is calculated as follows; 1. 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 ); 2. 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 )
Rate of Blood transfusion	6 weeks postpartum	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.; 1. 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 ); 2. 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 )
ICU admission rate	6 weeks postpartum	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)