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8th Postgraduate Course for Training in Reproductive Medicine and Reproductive Biology

Preterm Premature Rupture of the Fetal Membranes (Pprom) in Albania
A Proposal for a Research project

M. Gjoni

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 management approach.

Period of study

January 1999-December 2000

Study design

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:

  1. No vaginal examination at admission.
  2. 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.
  3. Diagnosis of pPROM by arborisation and ultrasound examination.
  4. Evaluation of fetal well-being by BPP (biophysical profile).
  5. Assessing maternal infection using the above mentioned criteria.
  6. Rutine antibiotic prophylaxis. Erythromycin, four times daily 100 mg.
  7. 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.

Outcomes measured

  1. General fetal and neonatal outcome (morbidity and mortality), matched according to the gestational age.
  2. Relation between duration of latent period and foetal/neonatal infection related to expectant management.
  3. Relation between the duration of the latent period and maternal infection, also during puerperium.
  4. Sensibility, sensitivity, positive predictive value and negative predictive value of BPP in monitoring foetal well-being at our obstetric units
  5. Induction success and failure rates between the two groups.
  6. If there is better feto/neonatal outcome with the expectant management.