Antibiotic Prophylaxis in Ragged Placental Membranes

Sponsor

Sarawak General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03459599

Collaborator

University Malaysia Sarawak (Other)

716

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometritis Postpartum Endometritis Membranes; Retained	Drug: Prophylactic antibiotics Other: No prophylaxis (Amox-clav withheld)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

716 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Prophylaxis Current protocol of administering antibiotics maintained	Drug: Prophylactic antibiotics 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
Active Comparator: No prophylaxis Antibiotics withheld, with appropriate observation and follow up	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

Arm

Intervention/Treatment

Active Comparator: Prophylaxis

Current protocol of administering antibiotics maintained

Drug: Prophylactic antibiotics

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

Active Comparator: No prophylaxis

Antibiotics withheld, with appropriate observation and follow up

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

Outcome Measures

Primary Outcome Measures

Incidence of postpartum endometritis [6 weeks postpartum]
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

Secondary Outcome Measures

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)
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 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 )
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. 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 )

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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