An interventional study of Prophylactic antibiotics and No prophylaxis (Amox-clav withheld) in Endometritis Postpartum, Endometritis and Membranes; Retained, sponsored by Sarawak General Hospital. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Sarawak General Hospital · Not applicable, Interventional, and Prevention
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.
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.
50 studies on the registry are indexed under Endometritis; 11 are open to participants now.
This study's enrollment of 716 is above the median of 300 across 38 interventional studies indexed under Endometritis.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Current protocol of administering antibiotics maintained
Drug: Prophylactic antibiotics
Antibiotics withheld, with appropriate observation and follow up
Other: No prophylaxis (Amox-clav withheld)
Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week
Also known as: Amox-clav given as per protocol
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
Also known as: Expectant management
Incidence of postpartum endometritis
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
Time frame: 6 weeks postpartum
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)
Time frame: 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 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 )
Time frame: 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. 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 )
Time frame: 6 weeks postpartum
No study locations are listed for this record.
Plan to share: No
Ran from Oct 2016 to primary completion in Mar 2017, 5 months.
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Sarawak General Hospital