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Completed

NCT Number: NCT03459599

Antibiotic Prophylaxis in Ragged Placental Membranes

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.

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Key information

Conditions

Endometritis Postpartum Adnexal Diseases Endometritis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Membranes; Retained Pelvic Inflammatory Disease Urogenital Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Antibiotics

Drug

Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week

Other names: Amox-clav given as per protocol

No prophylaxis (Amox-clav withheld)

Other

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 names: Expectant management

Primary outcomes

  1. Incidence of postpartum endometritis

    Time frame: 6 weeks postpartum

    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 outcomes

  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

    • 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 )

  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.

    • 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 )

Sponsors and collaborators

Lead sponsor

Sarawak General Hospital

Other

Collaborators

  • University Malaysia Sarawak

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2018
Registry last updated
Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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