Premature rupture of membranes (PROM) is when the bag of waters breaks and amniotic fluid leaks from the vagina before it’s time for you to go into labor.  Iatrogentic PROM occurs when the bag of waters breaks after a prior procedure where a needle or other instrument was inserted into the amniotic sac such as an amniocentesis or chorionic villi sampling.  Previable means that the PROM occurred very early in the pregnancy, too early for the pregnancy to be delivered and have a chance for the baby or babies to survive.   The diagnosis of PPROM is made with a sterile speculum exam to determine that fluid is leaking out of the vagina. In addition, an abdominal ultrasound is performed to measure the amount of amniotic fluid in the uterus and to see if the membranes (the linings of the sac) are detached from the wall of the uterus.  Severe detachment of the membranes, even without leakage of fluid from the vagina, may be treated with the amniopatch because of the high risk of complete breakage of the bag of waters.

The goal of the amniopatch procedure is to seal the membranes by placing glue like clotting substances inside the amniotic cavity (bag of waters).   This is typically performed on the labor and delivery unit. Following placement of an IV, under ultrasound guidance, a needle is inserted through your abdomen into the amniotic cavity (bag of waters). A small amount of fluid is obtained and sent to the lab to check for possible infection.   A glue like substance consisting of blood clotting cells (platelets) and clotting factors (cryoprecipitate) are injected into the amniotic cavity to help seal the membranes.    The entire procedure takes no more than 10-15 minutes.

INCLUSION CRITERIA:

1. Must be at least 16 weeks gestation
2. Diagnosed with iatrogenic PPROM or detached membranes that do not spontaneously seal (seal on its own).

 EXCLUSION CRITERIA:

1. Active labor or uterine contractions
2. Had vaginal ultrasound or digital vaginal examination (the doctor examined your cervix with his gloved hand) after you started leaking amniotic fluid.
3. Signs of intraamniotic infection (infection inside the bag of waters)
1. fever
2. uterine tenderness
3. foul smelling amniotic fluid
4. fetal tachycardia (the baby’s heart rate is faster than normal)