Endometritis PostpartumNCT03459599

Antibiotic Prophylaxis in Ragged Placental Membranes

A study testing Prophylactic antibiotics and No prophylaxis (Amox-clav withheld) in people with Endometritis Postpartum and Endometritis, run by Sarawak General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Endometritis Postpartum, Endometritis, Membranes; Retained
What is being tested?: Prophylactic antibiotics and No prophylaxis (Amox-clav withheld)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 716 participants
Where: No sites listed yet
Study dates: 1 Oct 2016to 1 Aug 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

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

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.

Read the 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.

Conditions: Endometritis Postpartum, Endometritis, Membranes; Retained
Being tested: Prophylactic antibiotics, No prophylaxis (Amox-clav withheld)
Keywords: Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes
Medical subject headings: Endometritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prophylactic antibioticsDrug
Also called Amox-clav given as per protocol
Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week
No prophylaxis (Amox-clav withheld)Other
Also called Expectant management
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

Study groups in NCT03459599
Study group	Role	What they receive
Prophylaxis	Active comparator	Current protocol of administering antibiotics maintained Receives: Drug: Prophylactic antibiotics
No prophylaxis	Active comparator	Antibiotics withheld, with appropriate observation and follow up Receives: Other: No prophylaxis (Amox-clav withheld)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6 weeks postpartum

Secondary outcomes (3)

ICU admission rate
ICU admission as a result of endometritis. It is measured as follows:
1. 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 )
2. 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)
Measured: 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 )
Measured: 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 )
Measured: 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20161 Aug 2017

First posted9 Mar 2018
Study start1 Oct 2016
Primary completion1 Mar 2017
Study completion1 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Endometritis PostpartumStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 716 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03459599
Sponsor's protocol ID: 16-1016-31034
Status last verified: Mar 2018
First submitted: 23 Feb 2018
Last updated: 12 Mar 2018
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25751198
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.
PubMed 2406660
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.
PubMed 21050523
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.
PubMed 25327508
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.
PubMed 26610697
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.
PubMed 8262292
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.
PubMed 31296180

Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial
ClinicalTrials.gov ID: NCT03459599
Acronym / sponsor ID: 16-1016-31034
Conditions: Endometritis Postpartum, Endometritis, Membranes; Retained
Keywords: Antibiotic, Endometritis, Placental membranes, Prophylaxis, Ragged membranes
Study type: Interventional
Recruitment status: Completed
Enrolment: 716 participants (actual)
Lead sponsor: Sarawak General HospitalUniversity, hospital or other
Collaborators: University Malaysia Sarawak
Study start: 1 Oct 2016 (actual)
Primary completion: 1 Mar 2017 (actual)
Study completion: 1 Aug 2017 (actual)
First posted: 9 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Prophylaxis	Active comparator	Drug: Prophylactic antibioticsCurrent protocol of administering antibiotics maintained
No prophylaxis	Active comparator	Other: No prophylaxis (Amox-clav withheld)Antibiotics withheld, with appropriate observation and follow up

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prophylactic antibioticsAlso: Amox-clav given as per protocolAmox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week	Drug	Prophylaxis
No prophylaxis (Amox-clav withheld)Also: Expectant managementWithholding 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	No prophylaxis

Primary outcome

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

3 secondary outcomes

ICU admission rate
Time frame: 6 weeks postpartum
Rate of surgical evacuation of retained products of conception
Time frame: 6 weeks postpartum
Rate of Blood transfusion
Time frame: 6 weeks postpartum

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Background: PubMed 25751198Meaney-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.
Background: PubMed 2406660Newton 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.
Background: PubMed 21050523van 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.
Background: PubMed 25327508Chongsomchai 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.
Background: PubMed 26610697Chibueze 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.
Background: PubMed 8262292Fernandez 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.
Derived from this study: PubMed 31296180Voon 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hian Yan Voon, MRCOG principal investigator

Sarawak General Hospital

Questions about this trial

What is this clinical trial studying?

A study testing Prophylactic antibiotics and No prophylaxis (Amox-clav withheld) in people with Endometritis Postpartum and Endometritis, run by Sarawak General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postpartum endometritis (time frame: 6 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459599, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.