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
About this trial
This is an interventional prevention trial for Endometritis Postpartum focused on measuring Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes
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
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
NCT ID
NCT03459599
First Posted
February 23, 2018
Last Updated
March 8, 2018
Sponsor
Sarawak General Hospital
Collaborators
University Malaysia Sarawak
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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Antibiotic Prophylaxis in Ragged Placental Membranes
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