Antibiotic Prophylaxis in Ragged Placental Membranes

NCT03459599 | Completed DMC

• 1 other identifier: 16-1016-31034
• Study Type: interventional
• Target: 716
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometritis Postpartum; Endometritis; Membranes; Retained

Keywords

Antibiotic; Endometritis; Placental membranes; Prophylaxis; Ragged membranes

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks postpartum

Secondary Outcomes (3)

• ICU admission rate

  6 weeks postpartum

• Rate of surgical evacuation of retained products of conception

  6 weeks postpartum

• Rate of Blood transfusion

  6 weeks postpartum

Study Arms (2)

Prophylaxis

ACTIVE COMPARATOR

Current protocol of administering antibiotics maintained

Drug: Prophylactic antibiotics

No prophylaxis

ACTIVE COMPARATOR

Antibiotics withheld, with appropriate observation and follow up

Other: No prophylaxis (Amox-clav withheld)

Interventions

Prophylactic antibiotics DRUG

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

Also known as: Amox-clav given as per protocol

Prophylaxis

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

Also known as: Expectant management

No prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sarawak General Hospital: lead
• University Malaysia Sarawak: collaborator

Related Publications (7)

• 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.

  PMID: 25751198 BACKGROUND

• 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.

  PMID: 2406660 BACKGROUND

• 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.

  PMID: 21050523 BACKGROUND

• 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.

  PMID: 25327508 BACKGROUND

• 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.

  PMID: 26610697 BACKGROUND

• 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.

  PMID: 8262292 BACKGROUND

• 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.

  PMID: 31296180 DERIVED

MeSH Terms

Conditions

Endometritis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Hian Yan Voon, MRCOG

  Sarawak General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 9, 2018
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share