Postgraduate Course for Training in Reproductive Medicine and Reproductive
Preterm Premature Rupture of the Fetal
Membranes (Pprom) in Albania
A Proposal for a Research project
Aim of the project
To evaluate the risks of infection and preterm labour
in pregnancies complicated by pPROM and advice the best possible management
leading to an optimal perinatal outcome.
To compare the outcomes between active versus expectant
Period of study
January 1999-December 2000
Type of study: Double blind case controlled.
Short background: We have an incidence of 3.1% of total
number of pregnancies complicated by pPROM. Amniorrhoea precedes about 23%
of the preterm births. The total number of deliveries per year is 6.500
to 7.500. Deliveries take place in the two University Hospitals.
Number of patients: A total number of about 400 pregnancies
is expected to be complicated by pPROM in the two years of study period.
Inclusion criteria : any pregnancy complicated by pPROM
between 28 to 36 completed weeks.
Exclusion criteria will be any complication of pregnancy
other than pPROM that involves fetal and neonatal outcome, e.g. IUGR, diabetes,
fetal malformations, pre-eclampsia. Upon these criteria, a total number
of 350 pregnancies will be enrolled in this study.
The STUDY GROUP will involve pregnancies complicated
by pPROM and managed expectantly in hospital No 2, which will account for
about 150 pregnancies.
Management will involve:
No vaginal examination at admission.
Evaluation of gestational age by amenorrhoea
for women having a regular cycle during the last three months before
getting pregnant, one ultrasound examination in the first trimester,
or at least two ultrasounds with an interval of two weeks from each-other
in the second and third trimester of pregnancy.
Diagnosis of pPROM by arborisation and
Evaluation of fetal well-being by BPP
Assessing maternal infection using the
above mentioned criteria.
Rutine antibiotic prophylaxis. Erythromycin,
four times daily 100 mg.
Tocolysis with magnesium sulphate for
a maximum of 24 hours, during that time dexamethasone 12mg twice parenteral.
The CONTROL GROUP will include about 200 pregnancies
complicated by pPROM, managed in Hospital No 1 for the same period of time
(two years). Most of the pregnancies at that hospital will be usually managed
actively, which means induction of labour after three days of oral steroids.
General fetal and neonatal outcome (morbidity
and mortality), matched according to the gestational age.
Relation between duration of latent period
and foetal/neonatal infection related to expectant management.
Relation between the duration of the
latent period and maternal infection, also during puerperium.
Sensibility, sensitivity, positive predictive
value and negative predictive value of BPP in monitoring foetal well-being
at our obstetric units
Induction success and failure rates between
the two groups.
If there is better feto/neonatal outcome
with the expectant management.
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Edited by Aldo Campana,