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Trial record 5 of 20 for:    "Endometritis" | "Anti-Bacterial Agents"

Antibiotic Prophylaxis in Ragged Placental Membranes

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ClinicalTrials.gov Identifier: NCT03459599
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborator:
University Malaysia Sarawak
Information provided by (Responsible Party):
Voon Hian Yan, 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.

Condition or disease Intervention/treatment Phase
Endometritis Postpartum Endometritis Membranes; Retained Drug: Prophylactic antibiotics Other: No prophylaxis (Amox-clav withheld) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2016
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : August 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 Name: 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 Name: Expectant management




Primary Outcome Measures :
  1. Incidence of postpartum endometritis [ Time Frame: 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 :
  1. ICU admission rate [ Time Frame: 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)


  2. Rate of surgical evacuation of retained products of conception [ Time Frame: 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 )

  3. Rate of Blood transfusion [ Time Frame: 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 )



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459599


Sponsors and Collaborators
Sarawak General Hospital
University Malaysia Sarawak
Investigators
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Principal Investigator: Hian Yan Voon, MRCOG Sarawak General Hospital

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Voon Hian Yan, Principal Investigator, Sarawak General Hospital
ClinicalTrials.gov Identifier: NCT03459599     History of Changes
Other Study ID Numbers: 16-1016-31034
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Voon Hian Yan, Sarawak General Hospital:
Antibiotic
Endometritis
Placental membranes
Prophylaxis
Ragged membranes
Additional relevant MeSH terms:
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Endometritis
Anti-Bacterial Agents
Antibiotics, Antitubercular
Pelvic Inflammatory Disease
Adnexal Diseases
Genital Diseases, Female
Uterine Diseases
Amoxicillin-Potassium Clavulanate Combination
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action