Amniocentesis Before rescue Cerclage

ISRCTN	ISRCTN18010960
DOI	https://doi.org/10.1186/ISRCTN18010960
Secondary identifying numbers	MSH Reference Number # 07-0080-A

Submission date: 30/10/2007
Registration date: 11/01/2008
Last edited: 11/01/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Wendy Whittle
Scientific

RM 3201
700 University Avenue
Toronto
M5G 1X8
Canada

Email	wwhittle@mtsinai.on.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study acronym	ABC Trial
Study objectives	We hypothesise that the use of a diagnostic amniocentesis and testing for rapid markers of chorioamnionitis (amniotic fluid lactate dehydrogenase or glucose level) will identify a subset of women without subclinical chorioamnionitis for whom the cerclage is more likely to prolong pregnancy to a viable gestational age and decrease the risk of neonatal and maternal complications.
Ethics approval(s)	Approval is pending as of 31/10/2007.
Health condition(s) or problem(s) studied	Cervical incompetence
Intervention	Women will be randomised to either: 1. Cerclage group 2. Amniocentesis and cerclage group Randomisation will be organised by a random numbers table and assigned by telephone. Women randomised to the amniocentesis group will undergo an aseptic aspiration of amniotic fluid under ultrasound guidance by a single operator. Briefly, the abdomen will be prepared with antiseptic solution and draped with sterile towels. The ultrasound transducer probe will be draped with a sterile plastic cover. Using a sterile water-based ultrasound gel to facilitate visualisation, the operator will identify a pocket of amniotic fluid suitably away from the foetus and placenta. A sterile 22 gauge needle will be passed into the uterine cavity under direct visualisation and approximately 15 cc of amniotic fluid will be aspirated. Post procedure, Rhogam™ will be administered to Rhesus negative patients as indicated. Amniotic fluid will be tested for lactate dehydrogenase level (2 cc), glucose level (2 cc), cell count (2 cc), haemoglobin level (2 cc) and Gram staining (2 cc). Amniotic fluid will be sent for confirmatory aerobic, anaerobic and myoplasma/ureaplasma culture (4 cc per culture). All tests will be performed by the respective Departments of Biochemistry, Haematology and Microbiology (Mount Sinai Hospital, Canada) using established protocols. While waiting for the fluid test results (approximately 90 - 120 minutes), a tocodynometer will be placed over the uterine fundus to confirm the absence of uterine activity. Those women without evidence of subclinical infection following amniocentesis and those women who were randomised to the cerclage group will have a rescue cerclage placed. Rescue cerclage placement will be performed under general anaesthesia. Women will be placed in the lithotomy position with a steep Trendelenberg tilt. The prolapsed membranes will be gently pushed back into the uterine cavity with an inflated Foley catheter. A single purse string suture (#5 Ticron™) will be performed using the technique described by MacDonald. Perioperative tocolysis (indomethacin 100 mg per rectum [pr] followed by 25 mg orally every 6 hours for 48 hours) to prevent the uterine contractions that can be precipitated by cervical manipulation and cerclage insertion and prophylactic antibiotics (clindamycin 900 mg intravenous [iv] three times a day [TID] for 7 days) will be administered. A transvaginal ultrasound to evaluate the cervical placement will be done 48 hours postoperatively. Following cerclage insertion, women will be restricted to bedrest until 30 weeks of gestation. Cerclages will be removed electively at 36 weeks or before based on foetal or maternal indication. Thromboprophylaxis with enoxaparin (40 mg subcutaneously [sc] once daily [od]) will be administered to all women on prolonged bed rest.
Intervention type	Other
Primary outcome measure	The primary comparison will be the prolongation of gestation to greater than 34 weeks of gestation, defined as rescue cerclage success.
Secondary outcome measures	1. Maternal morbidity: will include complications of cerclage insertion, through gestation and at the time of the delivery 2. Neonatal morbidity: will include complications during the initial admission to the nursery following the delivery
Overall study start date	01/01/2008
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	46
Key inclusion criteria	1. Singleton gestation 2. Presence of cervical dilatation 3. Membranes visible at or protruding through the cervical opening 4. Absence of any uterine activity 5. Absence of any overt signs of maternal infection: 5.1. Maternal temperature greater than 37.8°C 5.2. Diffuse abdominal pain 5.3. Foul/pus like discharge 5.4. Maternal or foetal tachycardia
Key exclusion criteria	1. Intrauterine foetal demise or distress 2. Intrauterine growth restriction 3. Foetal anomaly 4. Poly- or oligo-hydramnious 5. Ruptured foetal membranes 6. Current history of significant antepartum haemorrhage
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Canada

Study participating centre

RM 3201

Toronto
M5G 1X8
Canada

Sponsor information

Mount Sinai Hospital (Canada)
Hospital/treatment centre

c/o Dr Wendy Whittle
Department of Obstetrics and Gynaecology
Rm 3201 Ontario Power Generation Building
700 University Avenue
Toronto
M5G 1X8
Canada

Email	wwhittle@mtsinai.on.ca
Website	http://www.mtsinai.on.ca/
"ROR"	https://ror.org/05deks119

Funders

Funder type

Hospital/treatment centre

Mount Sinai Hospital (Canada) - Department of Obstetrics and Gynaecology Research Fund ($5000)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan