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Antibiotic Prophylaxis in Ragged Placental Membranes

Primary Purpose

Endometritis Postpartum, Endometritis, Membranes; Retained

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prophylactic antibiotics
No prophylaxis (Amox-clav withheld)
Sponsored by
Sarawak General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Endometritis Postpartum focused on measuring Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Prophylaxis

    No prophylaxis

    Arm Description

    Current protocol of administering antibiotics maintained

    Antibiotics withheld, with appropriate observation and follow up

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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)
    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 )
    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 )

    Full Information

    First Posted
    February 23, 2018
    Last Updated
    March 8, 2018
    Sponsor
    Sarawak General Hospital
    Collaborators
    University Malaysia Sarawak
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03459599
    Brief Title
    Antibiotic Prophylaxis in Ragged Placental Membranes
    Official Title
    Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2016 (Actual)
    Primary Completion Date
    March 1, 2017 (Actual)
    Study Completion Date
    August 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sarawak General Hospital
    Collaborators
    University Malaysia Sarawak

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endometritis Postpartum, Endometritis, Membranes; Retained
    Keywords
    Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    716 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Prophylaxis
    Arm Type
    Active Comparator
    Arm Description
    Current protocol of administering antibiotics maintained
    Arm Title
    No prophylaxis
    Arm Type
    Active Comparator
    Arm Description
    Antibiotics withheld, with appropriate observation and follow up
    Intervention Type
    Drug
    Intervention Name(s)
    Prophylactic antibiotics
    Other Intervention Name(s)
    Amox-clav given as per protocol
    Intervention Description
    Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week
    Intervention Type
    Other
    Intervention Name(s)
    No prophylaxis (Amox-clav withheld)
    Other Intervention Name(s)
    Expectant management
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Incidence of postpartum endometritis
    Description
    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
    Time Frame
    6 weeks postpartum
    Secondary Outcome Measure Information:
    Title
    ICU admission rate
    Description
    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
    Title
    Rate of surgical evacuation of retained products of conception
    Description
    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 )
    Time Frame
    6 weeks postpartum
    Title
    Rate of Blood transfusion
    Description
    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 )
    Time Frame
    6 weeks postpartum

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hian Yan Voon, MRCOG
    Organizational Affiliation
    Sarawak General Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25751198
    Citation
    Meaney-Delman D, Bartlett LA, Gravett MG, Jamieson DJ. Oral and intramuscular treatment options for early postpartum endometritis in low-resource settings: a systematic review. Obstet Gynecol. 2015 Apr;125(4):789-800. doi: 10.1097/AOG.0000000000000732. Erratum In: Obstet Gynecol. 2015 Aug;126(2):452-3.
    Results Reference
    background
    PubMed Identifier
    2406660
    Citation
    Newton ER, Prihoda TJ, Gibbs RS. A clinical and microbiologic analysis of risk factors for puerperal endometritis. Obstet Gynecol. 1990 Mar;75(3 Pt 1):402-6.
    Results Reference
    background
    PubMed Identifier
    21050523
    Citation
    van Schalkwyk J, Van Eyk N; INFECTIOUS DISEASES COMMITTEE. Antibiotic prophylaxis in obstetric procedures. J Obstet Gynaecol Can. 2010 Sep;32(9):878-884. doi: 10.1016/S1701-2163(16)34662-X.
    Results Reference
    background
    PubMed Identifier
    25327508
    Citation
    Chongsomchai C, Lumbiganon P, Laopaiboon M. Prophylactic antibiotics for manual removal of retained placenta in vaginal birth. Cochrane Database Syst Rev. 2014 Oct 20;2014(10):CD004904. doi: 10.1002/14651858.CD004904.pub3.
    Results Reference
    background
    PubMed Identifier
    26610697
    Citation
    Chibueze EC, Parsons AJ, Ota E, Swa T, Oladapo OT, Mori R. Prophylactic antibiotics for manual removal of retained placenta during vaginal birth: a systematic review of observational studies and meta-analysis. BMC Pregnancy Childbirth. 2015 Nov 26;15:313. doi: 10.1186/s12884-015-0752-4.
    Results Reference
    background
    PubMed Identifier
    8262292
    Citation
    Fernandez H, Gagnepain A, Bourget P, Peray P, Frydman R, Papiernik E, Daures JP. Antibiotic prophylaxis against postpartum endometritis after vaginal delivery: a prospective randomized comparison between Amox-CA (Augmentin) and abstention. Eur J Obstet Gynecol Reprod Biol. 1993 Aug;50(3):169-75. doi: 10.1016/0028-2243(93)90197-k.
    Results Reference
    background
    PubMed Identifier
    31296180
    Citation
    Voon HY, Pow JY, Tan LN, Suharjono HN, Teo WS. Antibiotic prophylaxis in ragged placental membranes: a prospective, multicentre, randomized trial. BMC Pregnancy Childbirth. 2019 Jul 11;19(1):240. doi: 10.1186/s12884-019-2373-9.
    Results Reference
    derived

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